Products and Solutions 2016 Roche Diagnostics Diagnostics – the building block of healthcare

Healthcare is undergoing a paradigm Roche, as global leader in diagnostics, shift. As people live longer, grow older and is pioneering this shift in the healthcare face serious illness – such as , landscape. Through our unrivalled heart disease and diabetes – there are investment in research and development; new challenges for both patients and our novel and medically differentiated care-givers. The strain on healthcare ­assays; our integrated systems; connected sys­ tems and resources is undeniable workflows and technologies, we are trans- but not insuperable. forming laboratory practice now and forever. As we continue to innovate across the A more intelligent and effective approach ­patient care pathway, we are pursuing our to healthcare is now in our grasp – vision of making data available anytime one in which in vitro diagnostics plays an and anywhere and delivering real value to integral role. healthcare systems.

Through providing the right information, The result is better, healthier lives for diagnostics enable healthcare professionals patients, and healthcare systems poised for to work more knowledgeably so that the long term. they can make better treatment decisions. Driving this change are the new biomarkers That is the power – the power of knowing. and testing technologies, which give laboratories an expanded role in delivering improved patient outcomes. The value of in vitro diagnostics Roche is the leader in Laboratories play a pivotal role in clinical Personalized Healthcare decision-making

IVD accounts for ~ 2 % of worldwide IVD influences > 60 % of clinical Diagnostics Pharmaceuticals healthcare spending decision-making

At Roche we combine technical competence with therapeutic insights.

Increased value of Diagnostics patients can now benefitfrom targeted With our leading Pharmaceuticals and identify patient subsets for clinical trials, In vitro diagnostics (IVDs) have long been treatments based on the presence of Diagnostics businesses under one roof, we and once the targeted medicine is in the considered as the “silent champion” of ­specific genetic defects or biomarkers in are better positioned to deliver Personalized marketplace, the approved IVD test is used healthcare, influencing over 60 % of clinical their or tissue. Targeted therapies Healthcare than any other company. An for treatment selection, response prediction decision-making, while accounting for only and diagnostic tests that help to improve exchange of know-how and intellectual and therapeutic monitoring. Personalized about 2 % of total healthcare spending. medical decision-making not only offer property, combined with our breadth of Healthcare is our core strategy and around clinical benefits for patients but arealso diagnostic technologies, allows for fast 60 % of our solutions in the pipeline involve The role of IVDs is set to grow with today’s attractive through health economic assay development and technical validation. this approach. changes in healthcare. With the develop- benefits­ to regulatory authorities and payers. A robust research diagnostic is essential to ment of Personalized Healthcare (PHC),

2 | 3 Our business strategy Differentiation with testing efficiency and medical value throughout the entire healthcare value chain

In modern healthcare, in vitro diagnostics decision-making along the entire continuum go far beyond simply telling a doctor of a patient’s health or disease, enabling • Revalue Diagnostics whether a patient has a certain disease physicians to make full use of IVDs along • Focus on unmet needs • Deliver clinical evidence or not. Today, they are an integral part of the healthcare value chain. Medical Value

• Total lab solutions

Screening Diagnosis Prognosis Stratification Monitoring Importance • Modular offerings Testing Efficiency • Comprehensive menues • Lab IT and workflow HPV NT-proBNP T HER2 Prothrombin time 2015 2020

Knowing whether Knowing whether Knowing whether Knowing whether Knowing you Roche Diagnostics differentiates itself We prioritize those areas with the highest a woman is a patient has a patient could it’s HER2 positive are taking the through innovation in testing efficiency unmet medical need and devote substantial at risk of , a die within 30 days breast cancer right dosage of and medical value resources to acquiring the necessary inte­ developing disease that after surgery anticoagulant cervical cancer can be misdiag- We develop evidence-based diagnostic tests llectual property to develop new tests and nosed half the that address unmet medical needs. Our then demonstrate their clinical utility and time based on tests and highly efficient laboratory solutions health economic benefit. symptoms alone help improve people’s health and quality of life. Increasing testing efficiency Healthy Asymptomatic/Symptomatic disease Chronic disease Roche continues to develop diagnostic Enhancing medical value solutions with improved speed, accuracy Improve people and patients’ lives and making healthcare sustainable Increasingly our efforts are concentrated on and reliability through automation, leveraging advanced scientific knowledge workflow, and IT integration. We enable and technological progress to increase the laboratories to better manage expanding Continuum of care with examples of diagnostic tests in different disease areas and the support they give in clinical decision-making. medical value of our diagnostic offering. testing and data volumes. We further Medical value is delivered by tests for drive laboratory efficiency by providing screening, diagnosis, prediction, and moni- our customers with modular solutions toring of disease, as well as by companion and comprehensive test menus. diagnostic tests used for treatment selection or predicting a patient’s response to a specific drug.

4 | 5 Roche Diagnostics’ areas of expertise “We are committed to delivering the best possible diagnostic solutions to improve people’s lives. Covering all in vitro diagnostic segments Sustainable healthcare depends on diagnostics, in all major healthcare areas and as the leader in the industry, we have the opportunity to shape healthcare delivery and to opti- mize resources in order to ultimately benefit society as a whole.”

Roche Diagnostics serves customers Roche Diagnostics offers the industry’s Roland Diggelmann, COO Roche Diagnostics spanning the entire healthcare spectrum – broadest range of diagnostic tests. Our from research institutions, hospitals and pioneering technologies and solutions not commercial laboratories to physicians and only help ensure an accurate diagnosis, patients. Performed on blood, tissue or they can detect the risk of disease, predict other patient samples, in vitro diagnostics how a disease may progress, and enable are a critical source of objective information the right treatment decision at the outset. for improved disease management and patient care. We help patients gain control over chronic conditions by enabling both physicians and patients to monitor treatment progress. And, through our successful collaboration with laboratories, we provide the fast and reliable results needed for life-changing We focus on all major healthcare areas ResearchResearch ClinicalClinical applications applications ResearchResearchResearchResearch Clinicaldecisions.Clinical applicationsClinical applicationsClinical applications applications Oncology Cardiology & Infectious diseases

Research Clinical applications

Academia Pharma Blood bank Commercial Hospital Physician’s Patient lab office homes AcademiaAcademiaAcademiaAcademiaAcademiaPharmaPharmaPharmaPharmaCommercialPharmaCommercial Commerciallab Commercial labHospital lablab Hospital labHospitalHospitalPhysiHospitalcianPhysi’s oPhysifficePhysicianc’siancPhysi oianffice’sPatient ’soc fficeoianffice’s homesoPatientfficePatientPatient homesPatient homes homes homes Academia• Life sciences Pharma• Blood •Commercial Central laboratory lab • MolecularHospital testing •Physi Self-testingcian’s office Patient homes • Sequencing screening • Point of care • Anatomic pathology • Life sciences• Life• •Lifesciences Life sciences sciences• Life sciences • Central •laboratory Central• Central laboratory • Centrallaboratorylaboratory • Molecular laboratory • Molecular testing • •Molecular Molecular •testing Molecular testing testing •testing Self monitoring• Self• Selfmonitoring• Self monitoring •monitoring Self monitoring • Life sciences • Central laboratory • Molecular testing • Self monitoring • Sequencing• Sequencing• •Sequencing Sequencing• Sequencing • Point of• carePoint• Point of care ofof• Point carecare •of Anatomic care • Anatomic pathology• •Anatomic Anatomic pathology• Anatomic pathology pathology pathology Blood safety Women’s health Critical care • Sequencing • Point of care • Anatomic pathology

6 | 7 Roche Diagnostics commitment Contents Providing innovation and excellence today and tomorrow

We offer a pioneering partnership Global and local expertise and dedicated Work Area soutions. �������������� 13 Elecsys® TORCH panel �����������������������������������������68 to make the maximum contribution service and support teams in over 130 cobas® modular platform ������������������������������� 14 Elecsys® Troponin T to patient care countries are there to support you every cobas® 8000 modular analyzer series ������������16 high sensitive (TnT hs) ������������������������������������������70 As a leader in IVD solutions, we are your step of the way. Our commitment and rich cobas® 6000 analyzer series �����������������������������20 Elecsys® NT-proBNP ���������������������������������������������72 dedicated partner supporting you through pipeline of differentiated solutions and cobas® 4000 analyzer series �����������������������������24 Lp(a), hsCRP and Homocysteine ����������������������74 our technologies for centralized and technologies are there all the way to sup- cobas c 111 analyzer �������������������������������������������26 Elecsys® IL-6, PCT and Tina-quant® CRP ���������76 decentralized settings, in molecular and port you in providing improved patient care COBAS INTEGRA® 400 plus �������������������������������28 Elecsys® portfolio �����������������������78 tissue testing as well as automation – today and also tomorrow. NEW cobas c 513 analyzer ����������������������������30 Elecsys® HE4 ������������������������������������������������������������80 and IT solutions. Automation & IT solutions �����������������������������������32 Elecsys® ProGRP ����������������������������������������������������82 cobas middleware solutions ������������������������������34 NEW Elecsys® SCC ��������������������������������������������84 In a pioneering partnership we provide cobas® infinity IT solutions ��������������������������������36 Elecsys® ������������������������������������������������86 products that increase testing efficiency Standalone and connected automation ���������40 Elecsys® Tg I I �����������������������������������������������������������88 and to deliver medical value, whilst cobas p 312 pre-analytical system �����������������41 Elecsys® Anti-TSHR �����������������������������������������������90 ­supporting you with our expert people cobas p 512 and cobas p 612 Elecsys® Vitamin D total ��������������������������������������92 worldwide. pre-analytical systems ������������������������������������������42 Elecsys® Anti-Mullerian Hormone (AMH) �����94 cobas p 501 and cobas p 701 Elecsys® sFlt-1/PlGF ����������������������������������������������96 post-analytical units ����������������������������������������������44 Tina-quant® Hemoglobin A1c ����������������������������98 MODULAR® PRE-ANALYTICS EVO �������������45 NEW The full SWA immunosuppressive cy M Total solution n e Pioneer in ie d ® c i cobas 8100 automated workflow series �����46 drug assay panel ��������������������������������������������������100 provider fi c Personalized f a e l Healthcare ® cobas connection modules (CCM) ���������������48 v g a n i l t u Overview of Serum Work Area tests ����������������50

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Personalized Comprehensive Turbidimetry – superior homogeneous Hemostasis testing ��������������������������� 103 solutions for different and differentiated

throughput needs testing menu immunoassay technology ������������������������������������58 NEW cobas t 411 coagulation analyzer 4����10

® Diagnostics excellence in Multiplate analyzer ��������������������������������������������106 Pa p rtnershi Infectious Diseases ����������������������������������������������������60 The Roche Hepatitis diagnostic portfolio ����������62 ® Global and local Commitment Elecsys HIV combi PT experts in >130 and innovation 4th Generation (Ag+Ab test) ������������������������������64 countries for diagnostics The test panel ������������������������������������������66 Elecsys® Syphilis immunoassay �������������������������67

8 | 9 Urinalysis ������������������������������������������� 109 COBAS® AmpliPrep/ Point-of-care testing ������������������������ 177 Hematopathology diagnostics �������������������������228 Urinalysis from Roche ������������������������������������110 COBAS® TaqMan® HIV-1 Test, v2.0 ���������������139 Overview of point-of-care Lung cancer diagnostic solutions ������������������230 Micral-Test® strip for albumin in urine ������111 COBAS® AmpliPrep/ diagnostic tests �����������������������������������������������������178 Prostate cancer diagnostics �����������������������������232 Combur-Test® strip ����������������������������������������������112 COBAS® TaqMan® HBV Test, v2.0 ������������������141 cobas® POC IT solution ������������������������������������181 Connectivity solutions �����������������������������������������233 Urisys 1100® analyzer ������������������������������������������113 COBAS® AmpliPrep/ NEW cobas® infinity POC mobile �������������184 VANTAGE workflow solution ����������������������������234 cobas u 411 urine analyzer �����������������������������114 COBAS® TaqMan® CMV Test ���������������������������143 cobas® bge link software ��������������������������������186 Companion diagnostics �������������������������������������236 cobas® 6500 urine analyzer series ����������������116 COBAS® TaqMan® MTB Test ����������������������������145 cobas b 221 system �������������������������������������������188 Digital pathology ��������������������������������������������������238 LightCycler® MRSA Advanced Test ���������������147 cobas b 123 POC system ���������������������������������190 cobas® 6800/8800 Systems �����������������������������148 Accu-Chek® Inform II solution ������������������������192 cobas® 4800 System ������������������������������������������150 cobas h 232 POC system ���������������������������������194 Molecular diagnostics ��������������������� 119 COBAS® AmpliPrep/ Roche CARDIAC® Trop T Sequencing solutions ���������������������� 241 Molecular diagnostics solutions ���������������������120 COBAS® TaqMan® System ��������������������������������152 Sensitive test ����������������������������������������������������������196 Genome Sequencer FLX+ System �����������������242 Test Overview ���������������������������������������������������������122 cobas® Liat System ���������������������������������������������154 CoaguChek® XS system �������������������������������������198 GS Junior System �������������������������������������������������244 cobas® HPV Test �������������������������������������������������124 cobas s 201 System �������������������������������������������156 CoaguChek® Pro II system ��������������������������������200 NimbleGen sequence capture �������������������������246 cobas® Oncology Portfolio �������������������������������126 NEW FLOW Solution ���������������������������������������158 Accutrend® Plus system ������������������������������������202 cobas® HSV 1 and 2 Test ���������������������������������128 LightCycler® Systems ������������������������������������������160 Reflotron® Plus system and cobas® Cdiff Test �������������������������������������������������130 LightCycler® 2.0 Instrument ������������������������������162 Reflotron® Sprint systems ���������������������������������204 cobas® MRSA/SA Test ��������������������������������������131 MagNA Pure Systems �����������������������������������������164 cobas b 101 system �������������������������������������������206 Consultancy services ����������������������� 249 NEW cobas® HCV for use on cobas p 480 instrument ������������������������������������166 Consultancy services ������������������������������������������250 the cobas® 6800/8800 System �����������������������132 cobas p 630 instrument ������������������������������������168 NEW cobas® HCV for use on cobas p 680 instrument ������������������������������������170 the cobas® 4800 System �����������������������������������133 Tissue diagnostics ���������������������������� 209 NEW cobas® HCV Genotyping Tissue diagnostics ������������������������������������������������210 Roche DiaLog ������������������������������������ 253 for use on the cobas® 4800 System �������������134 NEW VENTANA HE 600 system ������������������212 Roche DiaLog ��������������������������������������������������������254 COBAS® AmpliPrep/ Roche Blood Safety Solutions �������� 173 BenchMark Special Stains ��������������������������������214 COBAS® TaqMan® HCV qualitative NEW Roche Blood Safety solution �������������174 BenchMark IHC/ISH platform �������������������������216 Trademarks �����������������������������������������������256 and quantitative Tests, v2.0 �������������������������������135 IHC detection ��������������������������������������������������������218 NEW cobas® HIV-1 for use Primary antibodies �����������������������������������������������220 on the cobas® 6800/8800 System ����������������137 Breast cancer diagnostics ���������������������������������223 NEW cobas® HIV-1 for use on Cervical disease diagnostics ����������������������������224 the cobas® 4800 System �����������������������������������138 Colorectal diagnostics ����������������������������������������226

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Serum Work Area solutions

Laboratories have to manage critical work- Roche’s flexible cobas IT systems include Immunochemistry flow processes and provide uninterrupted middleware applications, laboratory infor- service. Our cobas® platforms offer fully mation systems and hospital point-of-care Clinical chemistry ­harmonized end-to-end solutions covering solutions. They enable you to use your everything from sample entry to result ­resources more effectively, while monitoring ­reporting and archiving. With their scalable laboratory performance and increasing Laboratories modular design, they can be customized quality and confidence. to meet any laboratories needs. IT solutions Our innovative and comprehensive Roche’s automated pre- and post-analytical test portfolio meets demands for workflow Elecsys solutions are integral to providing complete consolidation while also addressing flexibility and process optimization. We offer previously unmet medical needs. With our SWA solutions a full array of stand-alone and networked ready-to-use reagents and Elecsys® solutions to meet all of your laboratories immunoassay and DuREL homogeneous cobas needs. From laboratory layout to full imple- assay technologies, we guarantee mentation of systems and services, you can high quality results, combined with proven Pre- and post-analytics get everything from a single source. workflow convenience. An integrated solution combining IVD and For more information please IT reduces risk and complexity for your visit www.cobas.com laboratory.­

Instruments Automation • Designed to work together • Easy onsite upgradability Reagents • Maximum IT Solutions consolidation • Future proof

12 | 13 Back cobas® modular platform Flexible family concept for tailor-made solutions www.cobas.com

Today, laboratories are challenged to deliver Your benefit Product characteristics reliable and high-quality diagnostics, while Increased efficiency • Flexible combinations of clinical chemistry at the same time ensuring efficient analy­tical • Consolidation of 98 % or more of Serum (c) and immunochemistry (e) modules for workflow. To meet these demands, Roche Work Area workload Serum Work Area or dedicated immuno- has developed the cobas modular platform. • Consistent and predictable turnaround chemistry/clinical chemistry solutions It is an intelligent and flexible solution­ based times for smooth laboratory operation • More than 120 assays and applications on on a common architecture that delivers • Further enhanced automation through a the clinical ­chemistry platform, ready-to- tailor-made solutions for ­diverse workload broad offering of pre- and post-analytic use in cobas c packs and testing requirements. The cobas and ­cobas IT solutions from Roche • More than 100 assays on the immuno­ modular platform is designed to ­reduce chemistry platform, ready-to-use in the complexity of laboratory operation­ and Reduced complexity cobas e packs provide efficient and compatible solutions • Unique, ready-to-use reagents for maxi- for network cooperation. mum convenience of handling, ­minimal cobas® 8000 modular analyzer series >100 configurations logistic effort and cost-effective operation Large volume • Common look and feel of the user interface Unique reagent concept for maximum of on all systems for reduced training time handling convenience and minimal and flexible staff allocation logistic efforts Consistent and fast patient results cobas 6000 analyzer series 7 configurations • Standardized results across the entire Mid volume cobas­ modular platform ensured by using the same reagents

• 9 min. STAT assays for superior support of No mixing Ready to use Easy logistics emergency samples No preparation Fail-safe Minimal storage cobas 4000 analyzer series 3 configurations space Reliable and future proven Low volume • Proven Hitachi instrument reliability ­ensures maximum uptime for economic operation and reliable service to physicians • Over 30,000 cobas modular platform ­system installations worldwide

14 | 15 Back cobas® 8000 modular analyzer series Intelligent LabPower www.cobas.com

The cobas 8000 modular analyzer series Your benefit Consolidation is designed for high workload laboratories Efficiency • Real tailor-made solutions for every lab with a throughput of 2.5 to 15 million tests • Maximizes walk-away time and highly efficient change management per year. A modular configuration consists • Optimizes cost management • Maximizes throughput and consolidation of a core unit, an optional ISE unit (cobas • Improves sample turn-around time power without compromising workflow ISE module), and up to four analytical and availability • Consolidates very frequently requested modules: high throughput clinical chemistry tests with less frequently requested tests modules (cobas c 702 and ­cobas c 701), Productivity medium throughput ­clinical chemistry • Delivers throughput with maximum Product characteristics module (cobas c 502) and the immuno- ­consolidation power • High speed: From 170 to 680 immuno­ chemistry module (cobas e 602). • Manages peak times efficiently assay tests/hour and 2,000 to 9,800 • Multidimensional modularity: more than • Increases sample capacity on board ­clinical chemistry tests/hour depending 100 configurations for tailored solutions cobas 8000 modular analyzer series acts on configurations with fast on-site expandability intelligently, empowering the laboratory Process innovation • Up to 280 reagent channels • More than 120 clinical chemistry and to improve customer and patient services. • Ensures unrestricted rack traffic flow for ­almost 100 immunochemistry assays intelligent sample routing • Optimizes workflow Multidimensional modularity • Provides confidence in results Theoretical throughput (tests/hour, with ISE) 10,000

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16 | 17 Back cobas® 8000 modular analyzer series

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cobas 8000 modular analyzer series

1 cobas 8000 data manager 4 cobas c 702 module* 5 cobas c 502 module • Throughput of up to 170 tests/hour • Traceability records, for easy tracking • More than 120 assays and applications on • More than 120 assays and applications on • 25 reagent channels directly accessible of calibration and reagent information, the clinical chemistry platform including the clinical chemistry platform including for pipetting ­offers more transparency substrates, , proteins, DATs, and substrates, enzymes, proteins, DATs, • Carryover-free disposable tips • User-defined, fully automated, selective TDMs TDMs, and • Clot, liquid level, and air bubbles detection rerun and reflex testing • Throughput of up to 2,000 tests/hour • HbA1c (whole-blood measurement) • 70 reagent channels directly accessible • Throughput of up to 600 tests/hour 7 Module sample buffer 2 Core unit for pipetting • 60 reagent channels directly accessible • Capacity for 20 sample racks resulting • Loading capacity of 300 samples • Specimen integrity via serum indices, clot for pipetting in additional capacity of 100 samples • Unloading capacity of 300 samples and liquid level detection • Automatic reagent loading and unloading per module • Throughput of up to 1,000 samples/hour • Contact-free ultrasonic mixing during operation • Freely definable STAT positions • Dedicated STAT port • Specimen integrity via serum indices, clot • Environmentally controlled compartment • Optional sample rotation unit 4a Reagent manager and liquid level detection for 5 Auto QC racks • 10 reagent positions • Contact-free ultrasonic mixing • Backup operation port 3 cobas ISE module • Reagent RFID reader • Switch gates for shortcuts; gripper for • Sodium, potassium, and chloride • Continuous reagent cassette loading and 6 cobas e 602 module moving the racks from line to line • 900 or 1,800 tests/hour unloading during operation • Heterogeneous immunochemistry testing • Random access to racks; racks can go • ISE-specific sample probe with clot • Reagent cassette decapping with almost 100 assays for anemia, bone, from anywhere to everywhere ­detection • Reagent cassettes can be placed in ­tumor markers, hormones, cardiac and • Independent processing line the reagent manager at any time and ­infectious diseases as convenient • 9 min. STAT applications for hsTnT, * Alternatively, cobas c 701 module can be used. It is based on the same technology and it offers the same number of TnI, CK-MB, NT-proBNP, , PTH channels as cobas c 702, but has no ­reagent manager function. and hCG

18 | 19 Back cobas® 6000 analyzer series The success story continues www.cobas.com

The cobas 6000 analyzer series is a Your benefit Product characteristics First class performance member­ of the cobas modular platform Increased efficiency High system reliability • State-of-the-art immunoassay testing family. It offers medium to high workload • Perfect fit of throughput and reagent • More than 10,000 systems in operation ­using ECL technology labora ­tories tailor-made solutions for channels achieved across the seven worldwide • High quality results by ensuring sample ­clinical chemistry and immunochemistry different configurations • Proactive automated maintenance for and result integrity testing. Depending on the configuration, • Consolidation of 98 % of the Serum over 96 % uptime including maintenance the ­cobas 6000 analyzer series can be Work Area testing on a 24/7 basis Intelligent sample workflow placed in laboratories processing up to • Simplified lab processes and reduced costs • Combines STAT with routine testing 2.5 million tests per year. The cobas 6000 Unique reagent concept ­without disruption analyzer series is the result of vast know- Quality of results • No preparation and no mixing required, how, and decades of ­experience, combined • That you can trust and are right the economic usage with high stabilities and Professional management into one successful concept. With over first time convenient kit sizes of lab processes 10,000 systems in operation worldwide, • Predictable turnaround time • Wide range of pre- and post-­analytical the cobas 6000 analyzer series is the • Peace of mind solutions from small task target automa- most successful SWA analyzer worldwide. tion to total lab automation Maximum uptime • Highly reliable system based on more Delivers customized solutions for various work and testing requirements than 35 years of experience Tests per hour • Superior support provided by Roche ­organizations worldwide 2,000

Optimized workflow 1,500 • Wide range of pre- and post-analytical solutions and complete IT solutions 1,000 • Workflow efficiency and reduced ­complexity 500

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20 | 21 Back cobas® 6000 analyzer series The success story continues www.cobas.com

True workflow consolidation Just as every patient requires individualized care, every laboratory is unique. Striking a 2 balance between high standards and efficient operation requires tailor-made solutions.

1 3 4 cobas p 312 pre-analytical system is the ideal companion for the cobas® 6000 analyzer series, for a fully harmonized and complete solution. cobas 6000 analyzer series

1 Core unit • Throughput of up to 1,000 tests/hour Safe and efficient workflows with minimum The simplicity of this solution and the small • Loading and unloading capacity of • 60 reagent channels directly accessible complexity, using a single square meter space requirements allow its easy imple- 150 samples for pipetting footprint. The cobas p 312 pre-analytical mentation in almost any laboratory. • Throughput of up to 600 samples/hour • Automatic reagent loading and unloading system is Roche’s answer to fulfill automa- • Dedicated STAT port during operation tion needs of many small to mid-sized The cobas p 312 pre-analytical system will • Simple operation with continuous loading • Specimen integrity via serum indices, clot laboratories. It includes the necessary executes the following key tasks: and unloading and liquid level detection functionality to significantly improve labo- • Sample registration at a single entry point • Contact-free ultrasonic mixing ratory organization and increase workflow • Sorting and distribution of samples 2 Rack rotor efficiency. This on a single square meter. • Recursive workflow • Capacity for 20 sample racks 4 cobas e 601 module • Archiving • Freely definable STAT positions • More than 100 assays on the immuno- • Option of three Auto QC racks chemistry platform including ­anemia, • Random access for the racks bone, tumor markers, hormones, cardiac and infectious diseases 3 cobas c 501 module • 9 min. STAT applications for hsTnT, • ISE measurements (K, Na, Cl) TnI, CK-MB, NT-proBNP, Myoglobin, PTH • More than 120 assays and applications and hCG on the clinical chemistry platform • Throughput of up to 170 tests/hour ­including proteins, enzymes, DATs, TDMs, • 25 reagent channels, directly accessible substrates and electrolytes for pipetting • HbA1c (whole-blood measurement) • Carryover-free disposable tips • Clot, liquid level, and air bubble detection 22 | 23 Back cobas® 4000 analyzer series Freedom to realize your lab’s potential www.cobas.com

The cobas 4000 analyzer series is a Your benefit Product characteristics cobas c 311 analyzer member of the cobas modular platform Increased efficiency First class performance family and designed for laboratories • Consolidation of 98 % or more of Serum • More than 120 assays and applications processing 25,000 to 500,000 tests per Work Area workloads available including DATs, TDMs, specific year or 50 to 250 samples per day. proteins and whole blood HbA1c It consists of the cobas­ c 311 analyzer Maximum uptime • Throughput: up to 300 tests/h; ISE: 150 for clinical chemistry and the cobas • Highly reliable system based on more samples/h (corresponding to 450 tests/h) e 411 analyzer for immunochemistry than 35 years of experience testing. Together with cobas infinity • Superior support by Roche organizations Intelligent sample workflow standardized 3R (Request, Result, Reporting) worldwide • 108 sample positions with continuous solution and the ability to integrate the ­random access and flexible STAT priority • Disposable tips and cups for carryover- ­cobas p 312 pre-analytical system, the Quality of results settings free sample pipetting ­cobas 4000 ­analyzer series provides a • Integrated safety features for results comprehensive Serum Work Area solution you can trust Unique reagent concept Intelligent sample workflow that brings workflow­ efficiency to the • Predictable turn-around time • Convenient and error-free handling • 75 sample positions (rack system) next level. of cobas­ c packs • 30 sample positions (disk system) • Economic usage with high stabilities • Continuous random access and flexible and convenient kit sizes STAT priority settings Multiple LIS High system reliability Unique reagent concept • Programmable automated maintenance • Convenient and error-free handling cobas infinity 3R virtual automation functionalities of cobas­ e packs • Economic usage with high stabilities Product characteristics cobas e 411 analyzer and convenient kit sizes First class performance • More than 100 assays available High system reliability • Throughput: up to 86 tests/h • More than 12,500 analyzers installed • Superior immunoassay testing using worldwide ECL technology • High uptime of 99.8 % cobas p 312 cobas c 311 clinical cobas e 411 immunochemistry • 9 min. STAT applications including Troponin, pre-analytical system chemistry analyzer analyzer (rack system) CK-MB, Myoglobin, ß-hCG and PTH

24 | 25 Back cobas c 111 analyzer Small box. Big performance. www.cobas.com

The cobas c 111 analyzer is the smallest Your benefit Product characteristics member of the cobas® serum work area High quality of results World-class performance platform family and the ideal solution for • Comprehensive testing capabilities • More than 40 assays and applications ­clinical chemistry testing in laboratories • Results you can trust the first time, available including whole blood HbA1c, running ten to 50 samples per day. With a every time hsCRP, and D-dimer comprehensive test menu and easy inte- • Externally rated world-class performance1 gration of STAT samples, it can support Increased efficiency testing of both routine clinical chemistry • Essential routine testing on a small Good fit for labs <50 samples/day panels and rapid turnaround critical care ­footprint • Throughput of up to 100 tests/hour markers. In addition, the cobas c 111 • Simplified system operation • Compact benchtop system for labs with analyzer uses the same reagent formula- limited floor space tions as the larger cobas clinical chemistry Maximum uptime • Easy, intuitive software handling analyzers. This standardizes patient results, • Highly reliable system delivering which is vital to integrated laboratory net- > 99 % uptime High system reliability works serving outpatient services, emer- • Superior support provided by Roche • Robust system design gency departments and clinics, as well as organizations­ worldwide • Wizard-guided maintenance procedures private laboratories serving primary care physicians. Optimized workflow Network compatibility • Reducing complexity for a range of labo- • Ability to connect to local IT environment ratories, both networked or standalone • Common reagent chemistry across the • Consistent results across the cobas cobas® platform ­platform

cobas c 111 analyzer 1 Bowling, J.L., Katayev, A. (2010). Labmedicine, 41(7): 398-402.

26 | 27 Back COBAS INTEGRA® 400 plus The specialist in the routine laboratory www.cobas.com

The COBAS INTEGRA 400 plus analyzer is Your benefit Product characteristics the perfect solution for laboratories running High quality of results First class performance 50 to 400 samples per day. Its broad test • Results you can trust the first time, • More than 120 assays and applications menu comprises over 120 assays and appli- and every time available including clinical chemistry, cations that consolidate clinical chemistry ­specific proteins, TDMs, DATs and whole with specific proteins, therapeutic drug Increased efficiency blood HbA1c monitoring and drug abuse testing. This • Comprehensive testing capabilities on a compact tabletop analyzer offers maximum compact footprint Good fit for labs processing versatility to improve efficiency and reduce • Simplified processes and reduced costs 50 to 400 samples/day costs. It uses the convenient cobas c pack • Throughput of up to 400 tests/hour reagent format,­ which standardizes patient Optimized workflow • Compact benchtop system for labs with results across integrated laboratory networks. • Consistent results across the cobas® limited floor space ­platform High system reliability • Robust system design • Clot detection and pipetting safeguards

Unique reagent concept • Convenient and error-free handling of cobas c packs • Economic usage with high stabilities and convenient kit sizes

COBAS INTEGRA 400 plus

28 | 29 Back cobas c 513 analyzer NEW Setting a new precedent in HbA1c lab efficiency www.cobas.com

The prevalence of patients with diabetes Your benefit Product characteristics has been significantly increasing in recent Manages high HbA1c workload Analyzer Reagents years and is anticipated to rise by a further • Up to 400 HbA1c patient results/hour • High throughput of up to 400 HbA1c • Ready to use cobas c pack large 53 % until 2035. Managing the resulting patient results/hour • Tina-quant® HbA1c Gen. 3 growth of HbA1c testing volume is putting Fully automated and highly efficient • Test capacity of 14,000 determinations • Standardized according to IFCC a strain on healthcare providers. workflow on board ­transferable to DCCT/NGSP • Minimized operator intervention from • Closed tube sampling • Direct result reporting The cobas c 513 analyzer is a dedicated sample registration to result delivery • No need for sample pre-mixing (in IFCC and NGSP units) high throughput HbA1c solution designed • Closed tube sampling delivers maximum • Proven and trusted cobas technology to cope with this increasing HbA1c testing safety to the operator • cobas link for remote services volume. The analyzer offers a fully automated and highly efficient workflow by delivering up Proven result reliability to 400 patient results per hour, yet requiring • Standardized according to IFCC and minimized operator intervention from transferable to DCCT/NGSP sample registration to result delivery. Its • Delivers risk identification, diagnosis closed tube sampling function delivers and monitors the level of HbA1c maximum safety to the operator.

The cobas c 513 analyzer runs Roche’s ­established Tina-quant® HbA1c Gen. 3 test which is standardized according to IFCC and transferable to DCCT/NGSP in order to ensure high quality and standardized results. With no interference by most known HbA1c variants, Roche’s Tina-quant HbA1c assay delivers accurate risk identification, diagnosis and monitors the level of HbA1c delivering results that clinicians and patients can trust.

30 | 31 Back Automation & IT solutions Personalized Lab Automation www.cobas.com

At Roche, laboratory automation solutions 1. Virtual automation 1. Virtual automation deliver the quality and reliability you To have the control you need, ensuring cobas middleware solutions Workflow manager for your laboratory, consolidating Roche expect, with the personalization required quality and efficiency across your lab, instruments, third-party instruments and host systems to enable by low-, mid- and high-volume laboratories. virtual automation gives you the capability to efficient sample and data flow track your samples and reduce manual tasks cobas ® infinity IT solutions Scalable IT solution that goes beyond workflow management and With the most complete portfolio in the mar- through cobas IT solutions. operates across various lab disciplines. It provides modules ket, Roche's Personalized Lab Automation from connectivity, work area management and extended laboratory IT functionality provides the best customized solution for 2. Standalone automation every lab. Pre- and post-analytical tasks are automated, offering maximum efficiency through flexible 2. Standalone automation standalone solutions. It significantly reduces cobas p 312 pre-analytical system Maximum efficiency in a minimal space. A compact solution with manual steps in the lab, enhancing error single point of entry for all lab disciplines, sorting, decapping and handling, safety and process quality. archiving IVD test tubes

cobas p 512/p 612 High throughput solutions for sorting, decapping, extensive sample 1. Virtual automation 3. Connected automation pre-analytical systems quality inspection, aliquoting, and re-capping of IVD test tubes In addition to having all the benefits of cobas p 501/p 701 Refrigerated archiving systems enabling automated sample retrieval standalone automation, connected auto- post-analytical units and add-on test management mation offers transportation. Physically connecting different instruments allows for maximum predictability of time to 3. Connected automation test results. MODULAR® PRE-ANALYTICS EVO Consolidation of analytics and process organization through integration of automation solutions 2. Standalone automation Hospital network cobas® 8100 automated Fully automated solution featuring intelligent sample routing workflow series and prioritizing STAT workflow

cobas® connection modules Designed for high throughput labs. Connection of flexible pre- (CCM) analytical systems to analytical and post-analytics systems through a fast track

3. Connected automation Commercial Independent laboratories hospitals

3 Levels of Automation Customized solutions for every lab

32 | 33 Back cobas middleware solutions Intelligent workflow management for your laboratory

cobas middleware solutions are the Your benefit Easily accessible management information workflow manager for your laboratory, Effective use of your resources • Task-oriented for proactive exception conso­lidating Roche instruments, • Manage your laboratory instruments management third-party ­instruments and host systems and the people that use them from a • Sample archive management for automated to enable ­efficient sample workflows. single­ application or manual post-analytical phase Different IT solutions are available to meet • Expert system allows you to focus on regional customer needs (cobas IT ­critical information Save time and reduce duplication middleware & cobas infinity IT solutions). * of effort Improve quality performance • Configurable automated validation The intuitive automated validation and • High level of traceability and transparency with multiple levels of expertise ensuring quality control tools reduce operator through audit trail for each sample ­reproducible outcome ­intervention, while allowing laboratory • Support to achieve compliance with • Task-oriented and easy-to-use ­production to be monitored through regulations user interface ­real-time dashboards. Efficient workflows for today and the future Intelligent workflow management for your laboratory • Connects multiple instruments and soft- wares, multiple LIS from multiple sites • Scalable to follow the growth of your ­organization • Automated or manual pre-analytics and Pre-analytical Analytical Post-analytical post-analytics with complete traceability Sample ID and Result generation Add-on test tracking management Helping to improve your quality processes Sample preparation Quality control Archiving and retrieval • Quality control management including multi-rules and drift control

cobas middleware solutions * Please check with your local Roche representative for availability of the IT solution in your country.

34 | 35 Back cobas® infinity IT solutions One expert package to empower all www.cobas.com of your expertise

cobas infinity IT solutions is a web- cobas infinity IT solutions enables a Your benefit based application with scalable modules paperless workflow, and is structured around Right solution for every environment that are designed to manage complex work areas that focus on the tasks in hand. • Specialized modules designed for different lab processes and give sample testing and The unique workflow engine removes the test disciplines – matching the structure result data an efficient and transparent need to write complex rules to manage the and processes of different areas of the flow. It automates the three main areas of sample automation. Autovalidation enables laboratory. It helps automate many manual lab operations: pre-analytics, analytics efficient result management, and integrated tasks and optimizes productivity and post-analytics; but also extends beyond quality management tools organize the • Scalable and expandable for every kind the lab to ordering, blood collection quality process to support accreditation. of laboratory, now and in the future validation and reporting. Makes work flow • A comprehensive Integrated Quality • The unique workflow engine drives Management tool that not only manages Hospital network sample and data flow, streamlining job assay performance but also enables tasks and optimizing all process your organization to improve overall quality Hemato­ Urinalysis Micro­ logy biology steps in the different levels of automation processes supporting accreditation • Consistent look and feel across all user interfaces help staff learn quickly and POC SWA Standalone Extended lab enables better communication in and systems IT functionality across disciplines including Point of Care • Designed for easy of use on PC’s, tablets Blood Pre/Post­ Specimen safety analytics reception and mobile phones to see whats important Standalone lab and act fast- from wherever you are Flexile intelligence across lab disciplines and POC One decision for all choices – scalable to your needs and work areas. again and again. Dynamic production monitoring • Real time information for timely Designed to be easy to use, everywhere. decision-making with the live view tool • The Insights module retrieves retro­ spective accessible data from all process steps and turns the unsorted data into meaningful statistical reports to demonstrate lab performance

36 | 37 Back cobas® infinity IT solutions One expert package to empower all www.cobas.com of your expertise

cobas infinity central lab cobas infinity microbiology cobas infinity live view cobas infinity POC mobile • Empowering lab experts to manage • Turns testing complexity into efficient • See what’s important • Always with you complex processes workflow • Shares real time information for lab • A mobile application designed for POC • Designed for labs to manage complex • Designed for work area and technicians and lab managers on coordinators in hospitals to keep sample testing and result data flows in processes specific for microbiology. PC, tablets and mobile devices. While control and act on what is important an efficient and transparent way It offers management of cultures, out of the office, laboratory users while away from their PCs related biochemical testing and anti­- can access valuable real-time information cobas infinity central lab – 3R biotic susceptibility on turnaround time, sample load cobas infinity blood safety • Standardized for request, result, and and delayed samples in a core lab • Part of the Roche Blood Safety Solutions reporting in small labs cobas infinity total quality management • Optimizing process management and • Pre-configured central lab module • Empowering management of a high level cobas infinity insights monitoring for smaller labs for simple set-up with quality culture • Demonstrate your value as a trusted • Designed to increase workflow basic functionalities • Designed for proactive documentation-, partner efficiency by optimizing the specific issues-, indicators- and audits • Designed to turn objective lab statistics work area processes of the blood management to achieve and maintain into meaningful information to improve donor testing environment accreditation process performance and understand the value of the lab

cobas infinity lab link • Links health care professionals to your lab, from order to result cobas infinity central lab • Connects customers with the lab to streamline interactions when ordering

Ordering Blood Transport / Pre­ Analytics Validation Sample Reporting tests, checking patient results and collection scan analytics archiving automating the collection process for phlebotomists Pre-analytical Analytical Post-analytical

Manages more than the complexity of lab operations.

38 | 39 Back Standalone and connected automation cobas p 312 Personalized solutions for every lab pre-analytical system Compact automation for maximum efficiency www.cobas.com

Your benefit cobas p 312 pre-analytical is a standalone At an early pre-analytical stage, the solution offering maximum efficiency with automation solutions from Roche perform minimal space requirements. In less than a comprehensive inspection of sample 1 m2, cobas p 312 can be used for decap- quality and volume, maximizing an overall ping, sorting and archiving IVD test tubes. optimization of lab workflow through: • Early error detection May be used to automate and simplify • Reduced workload and reagents waste processes in clinical laboratories and blood Standalone automation offers maximum efficiency • Shortest time to consistent results banks. This compact standalone solution through flexible solutions that automate pre- and is validated for cross-contamination post-analytical steps in the laboratory Workflow your way compliance. Personalized workflows enable you to choose from primary, aliquot or mixed Product characteristics workflow • Compact automation in less than 1 m2 • Primary sample workflow – if the focus • Throughput up to 450 samples/hour is on cost efficiency • Registration of samples • Aliquot workflow – if the focus is on • Selective decapping of samples sample integrity and parallel testing • Archiving of samples • Mixed workflow – to optimize the • Flexible and freely definable input/output benefits of both sorting area • Traceability and control of lab process Short and predictable time to results Connected automation, besides having all the benefits • Improving patient care by offering of standalone automation, adds transportation by reliable results within predictable short physically connecting pre-analytics, analytics and cobas p 312 pre-analytical system post-analytics turnaround time, even during peak workflows

40 | 41 Back cobas p 512 and cobas p 612 pre-analytical systems www.cobas.com Adapting to today’s needs. Flexible for tomorrow’s demand.

Evolution of cobas p 512/612 pre-analytical • Tube type identification Product characteristics • Spin status detection: systems – new and innovative standalone • Sample volume check • Freely definable input and output Detects if blood samples have been solutions for high throughput laboratories. • Spin status detection sorting areas already centrifuged or not cobas p 612 differs from cobas p 512 • Sample quality check • Input with capacity of 600 samples and • Early detection and sorting of tubes due to the aliquot functionality. output of 1,200 samples with errors and issues Flexibility • Connection to a bulk loader • Selective decapping of sample tubes These standalone automation solutions Adapts to the lab’s sample handling needs. • Connection to single or double centrifuge • cobas p 612 includes an aliquoting are validated for cross-contamination • A solution compatible with all lab disciplines • Handling of Roche and non-Roche racks section with barcode labelling of compliance and therefore may be used to • Adapted sorting areas to your workflow and centrifuge buckets secondary tubes automate and simplify processes in to stay flexible • Throughput up to 1,400 samples/hour • Sorting of tubes directly into analyzers clinical laboratories and blood banks. • Single point of entry and bulk loading • Registration of primary samples target racks of tubes for convenient sample loading • Orientation of barcode in a • Archiving of processed samples with Your benefit • Long walk-away time “good-to-read” position optional recapping Innovation • Tube type identification • Upgradeability to connected automation The best answer to face emerging challenge­ s • Sample volume and quality check in laboratory operations. • Upgradable to connected automation • Easy to add functionalities • Comprehensive inspection of sample quality • Increased productivity in the same footprint

Quality comes first The new generation of cobas p 512/612 perform a comprehensive inspection of samples at an early stage, optimizing the lab workflow and ensuring the best use of time and resources. cobas p 512 pre-analytical system Complete configuration: cobas p 612 pre-analytical system with single centrifuge cobas p 471 and bulk loader module

42 | 43 Back cobas p 501 and cobas p 701 MODULAR® PRE-ANALYTICS EVO post-analytical units Pioneer in laboratory efficiency The automated archive

www.cobas.com

Product characteristics • Identification of primary sample tubes MODULAR PRE-ANALYTICS EVO is • Can be operated as standalone or • Automated storage, disposal and retrieval a modular system for the fully automated connected to cobas® 8100, cobas of sample tubes ­processing of primary samples from centrif- connection modules and MODULAR® • Selective recapping of tubes for storage ugation to archiving, including automated PRE-ANALYTICS EVO • Selective decapping of tubes for retrieval delivery of samples to cobas® 6000 analyzer • Storage throughput: up to 950 tubes/hour series and cobas 8000 modular analyzer • Retrieval throughput: up to 70 tubes/hour series. There are three models, plus options (retrieval, without influence on storage and upgrades to provide the greatest flexi­ throughput) bility. Thus, MODULAR PRE-ANALYTICS • Anytime easy access of samples due EVO meets a wide range of ­demands to the walk-in refrigerator area with regard to sample throughput, Your benefit • Storage capacity: laboratory layout, instrument­ s connected Full automation cobas p 501: 13,500 tubes and functionalities. • From sample entry to archive cobas p 701: 27,000 tubes • Reduced biohazard risks for personnel • Retrieval of samples within three minutes after ordering Consolidation of analytics • Reduced complexity with fewer analyzers and fewer process steps

Process organization • Streamlining of processes by providing IT networking of all components along with complete data and workflow management

Integration by automation • Shorter, predictable TAT • Reduction of labor-intensive processes

cobas p 501 post-analytical unit cobas p 701 post-analytical unit

44 | 45 Back cobas® 8100 automated workflow series 3-D intelligence in lab automation www.cobas.com

cobas 8100 intelligent tube transport • Primary sample workflow – if the focus provides a short predictable time to results, is on cost efficiency including prioritization for emergency • Aliquot workflow – if the focus is on samples. With flexible workflows, early error sample integrity and parallel testing detection and fully automated add-on • Mixed workflow – to optimize the benefits handling, cobas 8100 allows for personalized of both solutions to suit individual laboratory needs, guaranteeing that quality comes first. Short and predictable time to results • 3D intelligent tube transport improves Solution with cobas 8100 automated workflow series cobas 8100 covers the needs of high- patient care by offering reliable results throughput laboratories achieving 1,100 within predictably short turnaround times, Product characteristics samples/hour. Designed with options for even during peak workflows cobas® 8100 is made up of three stations: needs in order to optimize the required connectivity to Serum Work Area analyzers, • Multi-level and bidirectional tube transport: output, input and aliquot stations. Each workflow now. In the future, it can easily hematology, coagulation, selective third- empty tube holders and holders with tubes station can be configured according to the grow as needed. party analyzers and archiving, cobas 8100 run separately to avoid traffic jams number of samples and individual laboratory fully automates the laboratory process • Tubes always have a clear destination and from beginning to end. do not circle the track, guaranteeing first- in first-out sample processing Output station Input station Aliquot station Your benefit • Tubes can bypass modules if processing Quality comes first is not required At an early pre-analytical stage, Roche • Prioritized STAT workflow automation solutions check the sample quality and volume, maximizing workflow Flexible tube storage efficiency. A solution with cobas 8100 offers 3 storage 1 2 3 4 5 6 7 8 9 • Early error detection concepts, ensuring fast access as soon as • Reduced workload a tube is needed. • No reagent waste • Short-term storage for an immediate re-run 1 Restopper flex-cap/screw cap 6 Sample check module • Mid-term storage in the Add-on Buffer 2 Add-on/output buffer 7 Destopper Workflow your way Module – for optimized add-on request 3 Output buffer/sorter 8 Barcode labeler/tube feeder Personalized workflows enable you to choose processing within the same day 4 Input buffer 9 Aliquot module from primary, aliquot or mixed workflow. • Long-term storage 5 Automatic centrifuge unit

46 | 47 Back cobas® connection modules (CCM) Everything designed to work together as one www.cobas.com

cobas connection modules (CCM) allow Quality comes first • Adapted sorting areas to your workflow the connection of the standalone automation CCM performs a comprehensive inspection to stay flexible. Automates sorting areas systems, cobas p 512 and cobas p 612, of samples at an early stage, optimizing also for non-connected work areas to analytics and post-analytics through a the lab workflow and ensuring the best use • Long walk-away time fast track. of time and resources. • Flexibility of layouts with the possibility • Tube type identification to easily adapt for future changes You can still take advantage of the huge • Sample volume check flexibility of the standalone automation • Spin status detection Possible solutions concept, while adding predictability of time • Sample quality check The fast track to sample flow efficiency to results by getting connected through CCM connects pre-analytical system to cobas® connection modules. Workflow your way multidisciplinary targets streamlining and Personalized workflows enable you to optimizing laboratory processes. Your benefit choose from primary, aliquot or mixed Multidisciplinary connectivity workflow. CCM is a connected automation • Serum Work Area – cobas® 6000/8000 • Primary sample workflow – if the focus solution validated for cross-contamination analyzer series, MODULAR® ANALYTICS is on cost efficiency compliance and therefore may be used • Hematology – Sysmex HST/XN-9000 • Aliquot workflow – if the focus is on to automate and simplify processes in clinical hematology analyzers sample integrity and parallel testing laboratories and blood banks. • Coagulation – Stago STA-R Evolution® • Mixed workflow – to optimize the benefits Expert Series System and Stago STA-R of both workflows Combined forces for maximum value Max® System CCM can connect a cobas p 512/612 • Urinalysis – cobas® 6500 urine analyzer Flexibility pre-analytical systems to MODULAR series Adapts to the lab’s sample handling needs. PRE-ANALYTICS EVO. This combination • Molecular Diagnostics – cobas® 6800/ • A solution compatible with all lab makes it possible to maximize the 8800 system disciplines throughput of existing MPA systems, add • Post-analytics – cobas p 501/701 post- • Single point of entry and bulk loading of new features and connections. analytical unit tubes for convenient sample loading

Please note that not all versions are distributed in all countries. For further details contact your local affiliate.

48 | 49 Back Overview of Serum Work Area tests www.cobas.com

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modular modular modular modular modular modular ® ® ® ® 111 cobas c 111 analyzer cobas cobas c 111 analyzer cobas 111 cobas c 111 analyzer cobas cobas c 111 analyzer cobas platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: c module cobas modular platform: c module cobas modular 400 plus 400 plus platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: c module cobas modular platform: c module cobas modular 400 plus 400 plus Anemia CK-MB ••• Drugs of Abuse Testing Calcitonin • ••• CK-MB (mass) • (Ecstasy) •• Cortisol • Folate • CK-MB (mass) STAT • Barbiturates •• C- • Folate RBC • CRP hs ••• Barbiturates (Serum) • FT3 • Iron ••• Cystatin C •• Benzodiazepines •• FT4 • Iron binding capacity D-Dimer ••• Benzodiazepines (Serum) • hGH • •• – Unsaturated Digitoxin ••• Cannabinoids •• Hydroxybutyrate •• Soluble receptor •• Digoxin ••• Cocaine •• Dehydrogenase Transferrin •• GDF-155 • Ethanol •• IGF-14 • Vitamin B12 • HDL direct ••• LSD •2 • Insulin • ••• Homocysteine ••• Methadone •• ••• Bone Hydroxybutyrate Dehydrogenase •• Methadone metabolites •• PTH STAT • Calcium ••• LDL Cholesterol direct ••• (EDDP) T3 • N-MID Osteocalcin • Lipoprotein (a) •• Methaqualone •• T4 •• P1NP • Myoglobin ••• Opiates •• Thyreoglobulin (TG II) • Phosphorus ••• Myoglobin STAT • Oxycodone •3 • Thyreoglobulin confirmatory • PTH • NT-proBNP • Phencyclidine •• TSH • PTH (1-84) • NT-proBNP STAT •1 Propoxyphene •• T-uptake •• b-CrossLaps • Troponin I •1 Endocrinology Fertility Vitamin D total • Troponin I STAT • – pancreatic ••• Anti-Mullerian Hormone • Cardiac Troponin T hs • Amylase – total ••• DHEA-S • Apolipoprotein A1 •• Troponin T hs STAT • ACTH • Estradiol • Apolipoprotein B •• Coagulation Anti-Tg • FSH • Cholesterol ••• AT III •• Anti-TPO • hCG • CK ••• D-Dimer ••• Anti-TSH-R • hCG plus beta •

1 Not on cobas e 411 3 Not on cobas c 701 and c 702 5 Launch in 2016 Please check with your local Roche representative for 2 Not on cobas c 311 4 In development 6 Only on cobas c 501 and c 502 availability of the assays and tests in your country.

50 | 51 Back

www.cobas.com

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modular modular modular modular modular ® ® ® ® 111 cobas c 111 analyzer cobas cobas c 111 analyzer cobas cobas c 111 analyzer cobas cobas c 111 analyzer cobas platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: c module cobas modular platform: c module cobas modular platform: c module cobas modular platform: c module cobas modular 400 plus 400 plus 400 plus 400 plus LH • Anti-HBc IgM • Inflammation Metabolic Progesterone • Anti-HBe • Anti-CCP • (CO2) ••• Prolactin • HBeAg • ASLO •• Calcium ••• SHBG • Anti-HBs • C3c •• Chloride ••• Testosterone • HBsAg • C4 •• •• Hepatology HBsAg confirmatory • Ceruloplasmin •• Glucose ••• (IFCC) ••• HBsAg quantitative • CRP (Latex) ••• HbA1c (hemolysate) • •3 • ALT/GPT with Pyp • Anti-HCV • Haptoglobin •• HbA1c (whole blood) • •3 • ALT/GPT without Pyp ••• Chagas 4 • IgA •• Insulin • Ammonia ••• CMV IgG • IgE • Lactate ••• AST/GOT with Pyp ••• CMV IgG Avidity • IgG •• Magnesium ••• AST/GOT without Pyp ••• CMV IgM • IgM •• Potassium ••• – direct ••• HIV combi PT • Immunglobulin A CSF • Sodium ••• Bilirubin – total ••• HIV-Ag • Immunglobulin M CSF • Total Protein ••• Cholinesterase Acetyl •3 HIV-Ag confirmatory • • ••• Cholinesterase Butyryl •• HSV-1 IgG • Kappa light chains •• Triglycerides Glycerol blanked • Gamma Glutamyl Transferase ••• HSV-2 IgG • Kappa light chains free •6 • Vitamin D total • Glutamate Dehydrogenase •• HTLV-I/II • Lambda light chains •• Oncology HBeAg • Rubella IgG • Lambda light chains free •6 • Acid phosphatase •• HBsAg • Rubella IgM • Prealbumin •• AFP • Lactate Dehydrogenase ••• Syphilis • Procalcitonin • CA 125 • Infectious diseases Toxo IgG • Rheumatoid factor •• CA 15-3 • Anti-HAV • Toxo IgG Avidity • a1-Acid Glycoprotein •• CA 19-9 • Anti-HAV IgM • Toxo IgM • a1-Antitrypsin •• CA 72-4 • Anti-HBc • TPLA (Syphilis) •6

1 Not on cobas e 411 3 Not on cobas c 701 and c 702 5 Launch in 2016 Please check with your local Roche representative on 2 Not on cobas c 311 4 In development 6 Only on cobas c 501 and c 502 availability of the assays and tests in your country.

52 | 53 Back

www.cobas.com

® ® ® ®

modular modular modular modular modular ® ® ® ® 111 cobas c 111 analyzer cobas cobas c 111 analyzer cobas cobas c 111 analyzer cobas cobas c 111 analyzer cobas platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: e module COBAS INTEGRA platform: c module cobas modular platform: c module cobas modular platform: c module cobas modular platform: c module cobas modular 400 plus 400 plus 400 plus 400 plus Calcitonin • PTH (1-84) • Primidone • PAPP-A • CEA • Total Protein ••• Procainamide •• PlGF • Cyfra 21-1 • Total Protein, Urine/CSF •• Quinidine •• sFIt-1 • hCG plus beta • Urea/BUN ••• Salicylate •• P1NP • HE4 • Uric acid ••• Sirolimus • Progesterone • Kappa light chains free •6 • a1-Microglobulin •• Tacrolimus • Prolactin • Lambda light chains free •6 • b2-Microglobulin • Theophylline •• SHBG • NSE • Therapeutic drug monitoring Tobramycin •• Testosterone • proGRP • Acetaminophen (Paracetamol) •• Valproic acid • CMV IgG • PSA free • Amikacin •• Valproic acid free • CMV IgG Avidity • PSA total • Carbamazepine •• Vancomycin •• CMV IgM • SCC • Cyclosporine •• Women's health Rubella IgG • S-100 • Digitoxin ••• Anti-Mullerian Hormone • Rubella IgM • Thyreoglobulin (TG II) • Digoxin ••• AFP • Toxo IgG • Thyreoglobulin confirmatory • Everolimus • b-Crosslaps • Toxo IgG Avidity • b2-Microglobulin • Gabapentin6 • DHEAS • Toxo IgM • Renal Gentamicin •• Estradiol • Albumin (BCG) ••• Lidocaine • FSH • Albumin (BCP) •• Lithium • ISE free ßhCG • Albumin immunologic ••• Methotrexate6 • hCG • (enzymatic) ••• Mycophenolic acid •• hCG plus beta • Creatinine (Jaffe) ••• NAPA •• hCG STAT • Cystatin C •• Phenobarbital •• HE4 • Potassium ••• Phenytoin •• LH • PTH • Phenytoin free • N-MID Osteocalcin •

1 Not on cobas e 411 3 Not on cobas c 701 and c 702 5 Launch in 2016 Please check with your local Roche representative on 2 Not on cobas c 311 4 In development 6 Only on cobas c 501 and c 502 availability of the assays and tests in your country.

54 | 55 Back ECL – unique immunoassay technology Still light years ahead www.cobas.com

ECL (ElectroChemiLuminescence) is Roche’s Your benefit Product characteristics technology for immunoassay ­detection. Rapid response times ECL is an innovative technology with Elecsys® diagnostic markers with Based on this technology and combined • 93 % of assays with 18 min. assay time distinct advantages advanced assay design with well-designed, specific and sensitive or less • Extremely stable non-isotopic label for • Robustness against interference immunoassays, our Elecsys® tests deliver • 9 min. STAT applications for emergency long onboard stability and economic use (e.g. HAMA) due to a multidimensional reliable results. The development of ECL samples of reagents ­approach: blocking proteins, fragmented immunoassays is based on the use of a • High sensitivity for patient-friendly low catcher or tracer antibodies or chimeric ­ruthenium complex and tripropylamine. Wide measuring range sample volumes and fast results due to antibodies The chemiluminescence reaction for detec- • Linear signal response over six orders short turnaround times • Reference-traceable results with high tion of the reaction complex is initiated­ by of magnitude • Broad measuring range for fewer repeats ­lot-to-lot stability allow accurate long- applying a voltage to the sample solution and a streamlined workflow term monitoring resulting in a precisely controlled reaction. Low sample volume • High precision over the entire measuring • Unique reagent concept with ready-to-use, ECL technology can accommodate many • High analytical sensitivity allows low range for reliable results fail-safe and convenient reagent packs immunoassay principles while providing ­sample volumes • Applicable for the detection of all analytes ­(cobas e pack) for consistent handling superior performance. • Patient-friendly 10 – 50 μL per test for a broad assay menu including innova- • Consistently precise results across tive markers cobas­ ® immunochemistry platforms Controlled reaction based on standardized reagents and • High on-board stability and long shelf-life low inbuilt variability due to highly stable constituents ElectroChemiLuminescence (ECL) technology Precision and sensitivity • Superior low-end detection limits • Excellent precision over the entire measuring­ range

Attach Attach ­para- Attach to Voltage Signal count ruthenium magnetic electrode; starts microbead bound/free reaction separation

56 | 57 Back Turbidimetry – superior homogeneous immunoassay technology Integrate specific protein testing into your routine

Turbidimetry setting new standards: Your benefit Product characteristics Consolidation without compromise Efficiency and accelerated result re- Turbidimetry is Roche’s technology for The testing of “specific proteins” continues porting ­homogeneous immunoassay detection. to be one of the key routines in laboratories • High throughput without the associated Continuous development of the classical due to their wide-ranging clinical utility. cost of a dedicated instrument for protein antigen-antibody assay design to the pat- In the past, specific proteins were analyzed assays ented DuREL (Dual-radius enhanced latex) using a variety of specialized methods, • High sample throughput capability and technology forms the basis­ for high sensi- such as radial immunodiffusion, immuno- no sample split tivity and broad ­dynamic range detection. electrophoresis or using dedicated nephe- • Most efficient assay usage with high lometers. This incremental investment and ­onboard stability and low calibration The use of bichromatic wavelengths in the resulting additional costs, handling ­frequency spectrophotometry in conjunction with the complexity and reductions in throughput measurement of a sample blank minimizes were accepted due to the perceived benefits Consolidation without compromise interference effects. in performance offered by these methods. • Broadest specific protein menu on a fully consolidated platform including open Technological advances and future-oriented assay design Today, specific protein determinations are channel offering frequently carried out on consolidated, • Broad system platform portfolio for ­random-access clinical chemistry systems every lab size with standardized reagents using turbidimetric technology. Routine across the platforms ­efficiencies such as reduced turnaround times are thereby achieved for these ­parameters.

Classical HIA Latex-enhanced HIA DuREL

Differently-sized particles working together

DuREL technology Radius I Radius II Δ sce

0 20 40 60 80 100 100 140 160 cce 58 | 59 Back Diagnostics excellence in Infectious Diseases One step ahead

SDP SDP Elecsys immunoassays Molecular assays Anti-HAV total •• HBV DNA quantitative • Roche Diagnostics offers a comprehensive The extensive infectious diseases portfolio Anti-HAV IgM • HCV RNA qualitative • portfolio of infectious diseases assays is expanding every year. We are not only HBsAg •• HCV RNA quantitative • along the continuum of care, thereby en- focusing on launching new parameters HBsAg confirmatory • HCV genotyping • HBsAg quantitative HEV RNA qualitative abling laboratories to provide the right but we are also continuously updating •• • Anti-HBs •• hepatitis Viral MPX (HIV/HCV/HBV) • information, from screening and diagnosis our existing portfolio seeking continuous Anti-HBc •• DPX (B19V/HAV) • to patient management and treatment improvement, as well as keeping pace hepatitis Viral Anti-HBc IgM • CT DNA •• monitoring. with the evolution of pathogens. Anti-HBe •• CT/NG DNA •• HBeAg •• HSV1 and HSV2 DNA Our complete Infectious Diseases offer • Anti-HCV •• HIV RNA quantitative • includes and also molecular HIV combi PT •• STDs HIV RNA qualitative •• testing (please refer to chapter «Molecular HIV Antigen • HPV DNA • Diagnostics» for more information) which, HIV Antigen confirmatory • HPV genotyping • thanks to our Personalized Lab Automation Syphilis •• MPX (HIV/HCV/HBV) • solutions can be configured, connected Syphilis TPLA •• CMV DNA quantitative •• STDs and integrated to suit the requirements of Syphilis RPR ••• TORCH any laboratory. HSV-1 IgG •• HSV-2 IgG •• C. Difficile DNA • Each Roche Diagnostics infectious diseases HTLV-I/II •• MRSA DNA • MRSA/SA DNA test is designed with a clinical benefit CMV IgG •• • MTB DNA • in mind. A few examples that have been CMV IgM •• MAI DNA CMV IgG Avidity • Others • described in scientific publications are: HSV-1 IgG •• • • The Anti-HCV II and HIV Combi PT 2 HSV-2 IgG •• VRE • excel in seroconversion sensitivity allowing Rubella IgG •• West Nile Virus • 1-3 earlier intervention 1 Combined data from “Study report: Performance Rubella IgM •• Part of the Roche Blood Safety Solutions panel

evaluation CE: Elecsys Anti-HCV II; 20 Feb.; Version2; TORCH • Studies have confirmed the superior Toxo IgG •• 1 Study Number: CIM RD 001230/B10P010” In development capability of HBsAg and HIV Combi PT to Penzberg, Germany. Toxo IgM •• 2 For research use only detect mutants and rare variants, there- 2 Esteban, et al. (2013). J Med Virol. Toxo IgG Avidity • 3 Mühlbacher , et al. (2012). Med Microbiol Immunol. Syphilis fore driving screening effectiveness 4-7 Miller et al. (2010). (HIV). •• Please check with your local Roche representative on Syphilis TPLA •• the availability of the assays and tests in your country. • The CMV tests allow for a reliable 4 Ly et al. (2012). J Clin Virol. 5 Mühlbacher , et al. (2008). Med Microbiol Immunol. 6. Syphilis RPR ••• discrimination between an acute and a Jia, et al. (2009). Med Microbiol Immunol. Chagas 1 •• remote , therefore preventing 7 Louisirirotchanakul, et al. (2010). J Med Virol. 8 Revello, M.G. et al. (2012). Eur J Clin Microbiol Infect unnecessary repeat testing 8 Dis. (CMV) Others

60 | 61 Back The Roche Hepatitis diagnostic portfolio A clear direction ahead

Anti-HAV w v

HAV Anti-HAV IgM Every diagnostic test – from the initial many major reference and clinical research screening through to viral load testing – laboratories using Roche hepatitis products HBsAg II HBsAg II quant II can empower viral hepatitis treatment and services. decisions and improve patient outlook. Anti-HBc IgM Anti-HBs Not surprisingly, Roche customers regularly Roche offers the cobas® family of diagnostic leverage our experience as the provider HBsAg Anti-HBe confirmatory platforms to run all the tests required for of high quality hepatitis immunoassays and Anti-HBc HBeAg the screening, diagnosis and management the most clinically validated hepatitis viral HBV of viral hepatitis. With more than 25 load assays worldwide. HBeAg HBV DNA years of experience in the area of infectious quantitative diseases, Roche covers all relevant From screening to patient management, Anti-HBe diagnostic fields to help provide the best Roche’s diagnostic excellence and patient care. Roche is in more laboratories efficiency provides answers today for a Anti-HBs around the globe than any other vendor, with healthier tomorrow. HCV RNA HCV genotyping* HCV RNA qualitative quantitative

HCV Anti-HCV II

Reticulum

Iron

A clear Trichrome direction ahead in hepatitis AFP

General Hepatitis General ALTLP GGT-2 AFP

Bilirubin

Roche Serum Work Area Roche Tissue Diagnostics Roche Molecular Diagnostics *In development

62 | 63 Back Elecsys® HIV combi PT 4th Generation (Ag+Ab test) www.cobas.com Designed for early detection of HIV infection

The human immunodeficiency virus (HIV), Your benefit Product characteristics the causative agent of the acquired immuno- Earlier detection of infection Elecsys® HIV combi PT test deficiency syndrome (AIDS), belongs to the • Due to improved sensitivity by lysis of the characteristics family of retroviruses. HIV can be trans- virus using a pre-treatment (PT) step • Indications: Diagnostic use and for mitted through contaminated blood and screening of blood donations blood products, through sexual contact or Compliant with recent international • Fast results: 27 min. from an HIV infected mother to her child guidelines • Analytical sensitivity: ≤ 2.0 IU/mL ­before, during and after birth. Reliable • Analytical sensitivity ≤ 2.0 IU/mL Human immunodeficiency virus type 1 screening and diagnosis constitutes a crucial (HIV-1 p24 antigen) – 1st International aspect of the global strategy for reducing Robust to viral change Reference Reagent 1992, code 90/636 the ­human and financial burden of HIV • Multiple target concept to ensure ­excellent • Sample material: transmission. inclusivity: special detection of HIV-1 – Serum, standard or separating gel tubes subtypes, group O and HIV-2 antibodies – Plasma types: Li‑heparin, Na-heparin,

With the Elecsys HIV combi PT assay, the K2‑EDTA, K3‑EDTA, ACD, CPD, CP2D, HIV-1 p24 antigen and antibodies to HIV-1 Cost efficiency CPDA, Na-citrate and Li‑heparin plasma and HIV-2 can be detected simultaneously • High clinical specificity reduces the need tubes containing separating gel in one determination. This leads to improved for repeat testing • Low sample volume: 40 μL sensitivity and, therefore, a shorter • Clinical sensitivity: 100 % (n = 1,532) diagnostic window as compared to anti-HIV Elecsys® ARCHITECT® HIV-1 group M, O and HIV-2 ­assays. The assay uses recombinant AxSYM® ADVIA® Centaur • Clinical specificity antigens derived from the Env and Pol-­ eec – Blood donors: 99.88 % region of HIV-1 (including group O) and (95 % LCL: 99.77) (n = 7,343) 0 1.0 2.0 3.0 4.0 5.0 6.0 7.0 Days HIV-2 to determine HIV-specific antibodies. – Samples from unselected daily routine, e seces e s ssys Specific monoclonal antibodies are used css ee syses dialysis patients and pregnant women: for the detection of HIV-1 p24 antigen. 99.81 % (95 % LCL: 99.62) (n = 4,103) Comparison of the time required until acute infection The test includes an automated sample can be detected using different HIV antigen/antibody pretreatment step with detergent incubation combination immunoassays.1 in order to lyse HIV virions and ­maximize ­exposure of the HIV p24 antigen to 1 Mühlbacher, A. et al. (2012). Performance evaluation of a new fourth gen. HIV combination increase sensitivity. ­antigen-antibody assay. Med. Microbiol. Immunol. DOI: 10.1007/s00430-012-0250-5.

64 | 65 Back The Syphilis test panel Elecsys® Syphilis immunoassay Fully automated for complete ­assessment Confidence in all stages of treponemal of the disease syphilis infection

www.cobas.com

Syphilis is caused by the intracellular gram- Your benefit The Syphilis immunoassay has been negative spirochete bacterium Treponema • Reliable and complete solution using your ­designed using the latest recombinant pallidum subspecies pallidum. It is mainly algorithm of choice thermostable-antigen technology, to transmitted sexually, but can also be • Integrated with other tests in the TORCH achieve unprecedented high sensitivity ­transmitted from mother to fetus during and blood safety ­solutions portfolios and specificity performance across all pregnancy or at birth, resulting in • Treponemal test suitable for screening in stages of infection. congenital syphilis. Syphilis facilitates the the general population, pregnant women acquisition of HIV. and blood donations Your benefit Designed for high sensitivity Roche offers an automated panel of • High sensitivity minimizes the probability three assays for efficient and reliable of missing new Product characteristics assessment of syphilis patients. • Serum, standard or separating gel tubes Cost efficiency • Plasma types: Li-heparin, Na-heparin,

• High specificity reduces the need K2-EDTA, K3-EDTA, Na-citrate, ACD, CPC, ee cee ss for ­re-testing CP2D, CPDA and K2-EDTA plasma tubes containing separating gel • Syphilis • Syphilis • RPR Clear results interpretation • Sample volume: 10 μL • TPLA • TPLA • RPR • RPR • Clear cut-off separation of positive • Assay time: 18 min. and negative results • Test format: IgM/IgG (three antigens: Panel for the complete assessment of the syphilis patient. Screening, diagnosis, confirmation and activity monitoring of the disease. TpN15, TpN17, TpN47) TPLA and RPR are SEKISUI, Japan products distributed by Roche. Efficient use of sample volume • Clinical sensitivity: 100 % (n = 924) TPLA = T. pallidum Latex Agglutination • Maximizes the chance to order all the • Clinical specificity: 99.88 % (n = 8,079) RPR = tests required from the same sample – Blood donors: 99.93 % (n = 4,579) – Routine samples: 99.80 % (n = 3,500)

100 µL Vendor A 80 µL Vendor B 30 µL Vendor C 10 µL Elecsys® Syphilis

66 | 67 Back Elecsys® TORCH panel Reliable screening for early diagnosis www.cobas.com

Infections with Toxoplasma gondii, Rubella Your benefit Product characteristics virus, Cytomegalovirus (CMV) and Herpes High efficiency Roche has been continuously developing simplex virus (HSV) are especially risky • Consolidation of TORCH panel on cobas® innovative TORCH assays. Based on recom- during pregnancy. Prenatal diagnosis of immunology analyzers binant antigens and specific assay formats such infections is important and demands such as μ-capture and DAGS (double assays of outstanding quality and reliability. Early detection antigen sandwich), these assays combine • Allows early management of acute high clinical sensitivity and specificity. Opportunistic infections with Toxo and CMV ­congenital infections can also have severe consequences for Elecsys® Toxo IgM, IgG and IgG Avidity ­immunodeficient patients. A combination Fewer confirmation tests and • The Elecsys® Toxo IgM assay design and of high clinical sensitivity and specificity is fewer reruns respective cut-off minimize the probability Elecsys® CMV IgM, IgG and IgG Avidity therefore essential. • Due to highly specific assays of missing any new infection • Designed to detect all suspect primary • The Toxo IgG detects past infections with infections­ Fast reporting superior accuracy therefore immediately • Less sensitive to persistent IgM antibodies • Results in less than 20 min. ruling out non-relevant cases • Prevents cross reactivity with other • Combined use of the three assays herpes viruses allows accurate determination of primary Lower sensitivity to persistent IgM (not linked with a primary infection) infections Elecsys® HSV-1 IgG and HSV-2 IgG • Identification of silent carriers of Herpes Samples from pregnant women with positive CMV IgM values with routine assay but no Elecsys® Rubella IgM and IgG simplex virus infection evidence of a recent primary CMV infection (high-avidity IgG titer). Clearly discriminates between an acute • Type-specific assays for reliable and a remote infection differentiation between HSV-1 and HSV-2 Assay Site 1 (n = 20) Site 2 (n = 28) Site 3 (n = 20) • Rubella IgG test ultrasensitive to remote (two Elecsys HSV IgG assays available) Roche Diasorin ** Roche Siemens ** Roche Abbott ** infections Elecsys Liaison Elecsys Enzygnost Elecsys Architect • Complemented with early detection of Positive 6/20 20/20 4/28 28/28 7/20 20/20 acute infections by the Rubella IgM test IgM */Total

The combination of these assays provides * Pos = Ind + Pos ** Routine method in the lab. an excellent tool for identifying and charac- terizing Rubella infections. Revello, M.G. et al. (2012). Eur J Clin Microbiol Infect. Dis. 31(12), 3331-9.

68 | 69 Back Elecsys® Troponin T high sensitive (TnT hs) Improved performance – better clinical decisions www.cobas.com

In a clinical setting consistent with myo­ Your benefit Product characteristics cardial ischemia, detection of a rise and/or Guideline compliant • Fully automated test fall in troponin is the cornerstone of myo- • Test complies with the guidelines of ACC/ • Sample material: Heparin, EDTA plasma cardial infarction diagnosis. The Elecsys ESC* and NACB/AACC** and serum ­Troponin T hs test complies with the guide- • STAT test: 9 min. lines of ACC/ESC* and NACB/AACC** Safe and reliable results • 99th percentile upper reference limit*: in achieving less than 10 % coefficient of • Particularly at lower levels 14 ng/L (pg/mL) variation (CV) at the 99 percentile upper • 10 % CV precision: 13 ng/L (pg/mL) reference­ limit of the reference population. Earlier diagnosis • Greater sensitivity allowing the detection These requirements result in significant of more patients at risk Key benefit: Earlier diagnosis of AMI ­advantages in the diagnosis of acute Roche conventional cTnT Roche cTnT-hs ­coronary syndrome (ACS): High prognostic value for cardiac events 100 Using the cTnT-hs assay, results in • Significantly earlier detection of a cTn • Especially in patients with renal failure 80 NSTEMI compared with the conventional ­increase during an acute myocardial 60 cTnT test ­report: e ss infarction­ (AMI) Early identification 40 se • Time to diagnosis shorter by almost • Earlier rule-out and rule-in of AMI • Of acute and chronic myocardial damage 20 cs three hours

• Increased number of patients correctly that would not be discovered at all or only esls se 0 • 20 % more patients identified with a final Admission 1 2 3 4 5 6 diagnosed with AMI, thanks to the greater later with conventional cTn assays diagnosis of NSTEMI s e ss sensitivity and better analytical precision • Improved risk stratification of patients Consistent correlation Adapted from; Giannitsis, E. et al.Clin Chem (2010), 56(2), 254-261. with elevated cTn levels without acute • Between POC devices for emergency The 2015 ESC guidelines for the management of (ACS) without ST-segment elevation cardiac event testing and all cobas® immunoassay ­officially endorse the use of cTnT-hs in rapid diagnostic algorithms (T0/1-h; and T0/3-h) for the early rule-out/ rule-in of NSTEMI (Roffi, M. et al. (2015). Eur Heart J. [Epub ahead of print]). ­analyzers in the central lab These recommendations to adopt fast decision algorithms with hs troponin may help to reduce the hospitalization time considerably (and thus costs) and to improve patient care.

* ACC/ESC: American College of Cardiology/European Society of Cardiology. ** NACB/AACC: National Academy of Clinical Biochemistry/Academy of the American Association for Clinical Chemistry. * Elecsys® Troponin T high sensitive package insert.

70 | 71 Back Elecsys® NT-proBNP A leap forward in the diagnosis and www.cobas.com stratification of cardiovascular disease

Heart failure (HF) is a global health problem Your benefit Early diagnosis of HF associated with high morbidity and mortality. Simplified testing process and • Even in early stages without symptoms Detection in its early stages and appropriate improved efficiency of testing treatment are key objectives in improving • NT-proBNP provides 72 hour room Objectivity quality of life. Patients with HF – especially ­temperature stability without additional • NT-proBNP concentration correlates with with mild symptoms – are often not diag- processing severity of disease nosed. On the other hand, many patients • Test tube requirements allow one tube with suspected heart failure are unneces- ­solution for all cardiac markers Strong prognosis sarily referred to echocardiography. • High predictive value in cardiology risk Consistent correlation patients NT-proBNP is an innovative marker to im- • Between all cobas® immunoassay • Fast results: 9 min. as STAT assay prove clinical decisions. It delivers accurate ­analyzers and POC devices Improved therapy • Longer sample stability: 3 days at room data to help rule-out, rule-in, risk-stratify • Aids in the evaluation of the clinical ­temperature and even longer at 4° C or monitor patients. Fast diagnosis ­situation and optimization of therapy • High test precision (CV 2.9 to 6.1 %) • In cases of dyspnea; differentiation ­coupled with a wide dynamic measuring ­between cardiac or pulmonary causes Product characteristics range (5 – 35,000 ng/L) • Fully automated quantitative assay • Sample material: standard serum and • Low sample volume: 50 μL heparin/EDTA plasma Suspicion of acute heart failure because of symptoms and signs

NT-proBNP is formed by cleavage of proBNP Examination, ECG, X-ray and NT-proBNP

e Patient age (Years) NT-proBNP values (pg/mL) e < 50 <300 300–450 >450 scle 50–75 300–900 >900 >75 300–1800 >1800

el Interpretation Acute HF unlikely Acute HF less likely, Acute HF likely, consider alternative causes must confounding factors Half life 120 min. 20 min. ycl be considered sec s NPV = 98 % PPV = 92 % l

72 | 73 Back Lp(a), hsCRP and Homocysteine Improving cardiovascular risk assessment – www.cobas.com allowing better treatment decisions

Cardiovascular disease (CVD) is a major • Official guidelines recommend using Lp(a), Your benefit Consolidation health burden: a high proportion of hsCRP and Homocysteine, in combination Testing efficiency • Accurate and reliable measurement patients are not classified correctly or even with conventional risk analysis to aid in the • Cost-effective, fast, robust, easy to on a fully consolidated platform missed entirely for cardiovascular (CV) evaluation of CV risk assessment.2–4 This perform with excellent accuracy and risk assessment leads to a more accurate categorization precision due to advanced assay design •0 Up to 7 % of those who develop coronary of individuals at increased risk for CV events have only one, or even none of the disease 5 (figure 2) Standardization 1 Young, I., Rifai, N. (2009). Clin Chem. 55, 201– 2. traditional risk factors, and more than half • Consistent patient results across all care 2 Nordestgaard, B.G. et al. (2010). Eur Heart J. have either normal or mildly increased settings due to standardized reagents on 31(23), 2844–53. 3 Perk, J. et al. (2012). Eur Heart J. 33(13), 1635 –701. lipid values1 (figure 1) all Roche systems 4 Refsum, H. et al. (2004). Clin Chem. 50, 3–32. • Excellent correlation to the reference 5 Montgomery, J.E., Brown, J.R. (2013). Vasc Health method/material Risk Manag. 9, 37– 45. Figure 1: Only up to 70 % of cases can be identified

Product characteristics

Assay Tina-quant® Homocysteine Cardiac C-Reactive Lipoprotein (a) Gen. 2 enzymatic Protein High Sensitive

Sample material Serum, Plasma Serum, Plasma Serum, Plasma

LDL HDL Sample volume 2 µL 14 µL 6 µL Assay time 10 min. 10 min. 10 min. Cholesterol Smoking Blood pressure Age Gender Weight Height Measuring range 7– 240 nmol/L 3 – 50 µmol/L 0.15 – 20 mg/dL Onboard stability 42 days 28 days 84 days Figure 2: 90 % of cases can be identified Calibration frequency With every lot With every lot With every lot Precision (cobas c 501 module) - Repeatability 0.8 – 5.6 % 1.4 – 2.0 % 0.4 –1.6 % - Intermediate precision 1.1– 8.0 % 1.8 – 2.3 % 2.1– 8.4 % Traceability SRM2B for nmol/L NIST SRM 1955 BCR470/CRM470

+ HCY Lp(a) hsCRP HDL LDL

74 | 75 Back Elecsys® IL-6, PCT and Tina-quant® CRP For early and effective sepsis management – www.cobas.com because time matters

Sepsis, the systemic inflammatory response Your benefit PCT, IL-6 and CRP: a to infection, is a leading cause of death. Rapid diagnostics panel to support early recognition With 18 million global cases annually, it is • Short total assay time and management of sepsis a major burden on healthcare. IL-6: Early warning sign of (systemic) Testing efficiency ­inflammation and sepsis Early recognition is critically important • All parameters from one sample tube PCT: Follows IL-6 and indicates high for patient survival, but clinical signs and ­probability of bacterial sepsis symptoms are often ambiguous. Economical sample handling CRP: Released from the liver as a later • Low sample volumes, especially important marker of inflammation Elecsys IL-6, Elecsys BRAHMS PCT, in for pediatrics combination with CRP, deliver rapid, reliable Product characteristics information about the patient’s immediate Assay Elecsys BRAHMS PCT Elecsys IL-6 CRPL3 on inflammatory status and likelihood of cobas c analyzers ­bacterial sepsis, which is important for Sample material Serum, Li-heparin and Serum, Li-heparin Serum, Li-heparin and K3-EDTA plasma and K2- and K3-EDTA K2- and K3-EDTA plasma ­antimicrobial therapy management. plasma Sample volume 30 µL 30 µL 2 μL Assay time 18 min. 18 min. 10 min. Acute inflammatory Clinical indication Differential Severe sepsis/shock Measuring range 0.02 – 100 ng/mL 1.5 – 5,000 pg/mL 0.3 – 350 mg/L episode of sepsis ­diagnosis Analytical sensitivity <0.02 ng/mL 1.5 pg/mL 0.3 mg/L Suspicion/treatment characterization Therapy stewardship of infection* Functional sensitivity <0.06 ng/mL 5 pg/mL 0.6 mg/L Traceability Standardized against WHO Standard NIBSC IRMM reference prepa- • IL-6 • Temperature •  • PCT BRAHMS PCT LIA 1st IS 89/548 ration CRM470 (RPPHS) • Heart rate – PCT • IL-6 • Breathing rate – IL-6 • Leukocytes – CRP • CRP * Rapid identification of sepsis pathogens is possible with LightCycler® SeptiFast Test. Please see on page 65 for more details.

76 | 77 Back Elecsys® tumor marker portfolio Supporting improvements in cancer diagnosis and monitoring

In the last decade, the sensible use of Reliable results Roche reagent and application portfolio for consolidated tumor marker testing tumor markers and the careful interpretation • Robustness against interference Test Cancer indications Roche/ COBAS cobas e MODULAR cobas c of their results have led to the continuous (e.g. HAMA) by blocking proteins, Hitachi INTEGRA systems ANALYTICS systems enhancement of their clinical significance. ­fragmented catcher or tracer antibodies systems EVO AFP Liver, testicles   The inclusion of tumor markers in clinical or chimeric antibodies1 Calcitonin Medullary, carcinoma   management can help to provide more • Standardized to international standards CA 125 Ovary   ­information for improved clinical decision- or, if no standard available, traceable to HE4 Ovary   making and therefore maximize the quality a commonly accepted methodology CA 15-3 Breast   of care. Nowadays, therapy management of CA 19-9 Pancreatic, colorectal   cancer patients is guided by tumor marker Operational efficiency CA 72-4 Gastric, colorectal,   mucinous ovarian measurements based on the individual • High degree of system automation CEA Colorectal- and lung   base line levels before and ­after primary • Less retesting due to high precision and adenocarcinoma treatment. An excellent long-term assay wide measuring ranges CYFRA 21-1 Non small cell lung   accuracy, lot-to-lot stability and precision is • Broad tumor marker menu with specialties Ferritin Tumor related anemia      crucial for the reliable evaluation of signifi- such as CA72-4, S100, NSE, CYFRA 21-1, HCG Chorion       cant differences in ­tumor marker levels in HE4, and ProGRP ß2 Microglo- Multiple myeloma bulin (non-Hodgkin) cancer patients during therapy monitoring • Outstanding degree of SWA consolidation NSE Small cell lung   and follow up. with > 210 parameters for clinical chemistry ProGRP Small cell lung   and immunochemistry SCC Squamous cell lung, cervix   Your benefit Free PSA Prostate   Longitudinal accuracy for reliable Complete diagnostic picture with Total PSA Prostate     long-term patient monitoring Per­ sonalized Healthcare S100 Malignant melanoma Anti-TG Medullary, thyroid carcinoma   • High reproducibility and analytical • Coverage of the whole chain from Tg II (hs) Medullary, thyroid carcinoma   precision over the entire measuring range, diagnostics, therapy decision and moni- especially in lower concentration ranges toring by Roche’s broad oncology menu • High lot-to-lot consistency across all in tissue diagnostics, Elecsys tumor ­cobas® platforms markers and molecular solutions

1 Bolst ad, N. et al (2011). Heterophilic antibody interference in commercial immunoassays. Clin Chem Lab Med 49(12), 2001-2006.

78 | 79 Back Elecsys® HE4 An oncological biomarker improving ­ovarian www.cobas.com cancer­ care

Worldwide, ovarian cancer is the second Your benefit ROMA increases the diagnostic value Product characteristics leading cancer in women and the fourth Early marker with increased sensitivity of the dual marker combination HE4 • Assay time: 18 min. most common cause of death from cancer. for supporting the diagnosis of epithelial and CA 125 • Sample material: Serum collected using It is a gynecological disease with one of ovarian cancer (EOC) Measured values of HE4 and CA 125 can standard sampling tubes or tubes con- the highest mortality rates. • As a single tumor marker, HE4 had the be combined in an algorithm called ROMA taining separating gel Li-heparin plasma, greatest sensitivity (at a specificity of — which takes into account the menopausal K2-EDTA and K3-EDTA plasma The more the disease has progressed, the 75 %) in detecting of EOC, especially in status of the woman. Several published • Sample volume: 10 μL lower the survival rate is and unfortunately the early non-symptomatic stage studies show that ROMA helps in the triage • Limit of detection: 15 pmol/L most cases of ovarian cancer are ­detected of pre- and postmenopausal women sus- • Measuring range: 15 – 1,500 pmol/L in later stages where the chances of cure High discrimination between benign pected of having ovarian cancer. Moore et • Intermediate imprecision cobas e 411 are rather low. ovarian masses/cysts and ovarian al. (2009) found that the algorithm correctly ­analyzer, Elecsys 2010 analyzer: 2.7 – 4.3 % cancer classified 94 % of women with epithelial cobas e 601/e 602 modules, E170: 2.6 – 3.4 % In the early stages of ovarian cancer, symp- • The combination of HE4 and CA 125 ovarian ­cancer.1 This high accuracy in • Repeatability cobas e 411 analyzer, toms are unspecific and cause little, if any, shows the greatest accuracy in differen­ stratifying women with low or high risk for ­Elecsys 2010 analyzer: 1.3 – 1.8 % discomfort. Therefore, new methods and tiating between patients with EOC vs. EOC contributes to better diagnosis, treat- cobas e 601/e 602 modules, E170: 1.5 – 1.9 % biomarkers which can help in diagnosing those with benign pelvic masses ment and outcome. this disease at an earlier stage are highly desirable. The biomarker HE4 (human epi- Improved monitoring of ovarian cancer didymal protein 4) together with the marker recurrence and progression elc ss s lcy l CA125 can play a very important role here. HE4 correlates with the recurrence status in women with a diagnosis of EOC and is an eesl sesl earlier marker for recurrence than CA 125. PI = -12.0 LN[HE4] LN[CA125] PI = -8.09 LN[HE4] LN[CA125] PI = predictive index Reliable results with efficiency le e e • Excellent precision and lot-to-lot (exp(PI) = ePI) consistency­

• Comprehensive tumor marker menu <11.4% ≥11.4 % <29.9 % ≥29.9 % ­available on all cobas® platforms low risk high risk low risk high risk Calculation of the ROMA-values for pre-and postmenopausal women and individual cut-points for the Elecsys assays to separate between low and high risk patients.

1 Moore, R.G. et al. (2009). A novel multiple marker bioassay utilizing HE4 and CA125 for the prediction of ovarian cancer in patients with a pelvic mass. Gynecologic Oncology, 112, 40-46. 80 | 81 Back Elecsys® ProGRP Crucial information for differential diag­ nosis www.cobas.com in lung cancer and monitoring of small-cell lung cancer patients

Progastrin-releasing peptide (ProGRP) In future, lung cancer biomarkers such as • Lung cancer biomarkers available on a is a tumor marker with benefits for the ProGRP can also play an important role in single automated platform – CEA, CYFRA management of small-cell lung cancer assessing therapy resistance of patients 21-1, NSE, ProGRP and SCC patients.­ ­receiving targeted EGFR-tyrosine kinase • Equivalent performance between plasma ­inhibitor (TKI) therapies. It has been de­ and serum for flexibility and ­convenience, Lung cancer is one of the most common monstrated that a subset of NSCLCs with thus offering advantages over existing in the world with 1.35 million new mutated EGFR return as SCLC when resis- assays2 cases diagnosed every year. The two main tance to EGFR-TKIs develops and that this histological types of the disease are small is caused by a transformation from NSCLC Product characteristics cell lung cancer (SCLC) and non-small cell to SCLC.1 • Assay time: 18 min. lung cancer (NSCLC). It is important to • Sample material: • Sample volume: 30 μL ­distinguish between these two subtypes Your benefit – Serum collected using standard • Limit of detection (LoD): 3 pg/mL as they have different treatments and prog- • High sensitivity and discrimination aiding ­sampling tubes or tubes containing • Measuring range (lower end defined noses. NSCLC (approx. 80 % of cases), the accurate differential ­diagnosis of SCLC separating gel by LoD): 3 – 5,000 pg/mL when in the early stages, is curable with • Excellent precision across the entire – Li-heparin plasma, K2-EDTA and surgery. SCLC, however, is an aggressively measuring range for reliable results K3-EDTA plasma spreading neoplasm of rapid growth that is usually only treatable with chemo and N=105 N=748 N=37 N=169 radiotherapy. cce 120,000 eel >80.1pg/mL 20,000 ss ProGRP is the tumor marker of choice for 5,000 SCLC as it aids in quick and decisive ProGRP 1,000 ­discrimination between SCLC and NSCLC serum/plasma 200 <80.1pg/mL 100 for faster decisions on patient treatment. level 50 20 ProGRP is also a tumor marker that can be The 80.1 pg/mL cut-off value is based on the 95 % 10 used to assess response to therapy as well ­specificity of the NSCLC collective. 3 NSCLC NSCLC SCLC SCLC as to monitor recurrence of the ­disease. China EU China EU

1 Oser , M.G. et al. (2015). Transformation from non-small cell lung cancer to small-cell lung cancer: Use of ProGRP for the primary differential diagnosis in lung cancer. The ability of ProGRP to distinguish molecular drivers and cells of origin. Lancet Oncol.; 16: e165-172. SCLC from NSCLC was investigated in a study on 1059 patients in 5 centers in Europe and China 2 K orse, C. et al (2015). Multicenter evaluation of a new progastrin-releasing peptide (ProGRP) (206 SCLCs and 853 NSCLCs), and ProGRP levels were correlated with biopsy proven histology. immunoassay across Europe and China. Clinica Chimica Acta 438, 388-395. (Source: Elecsys ProGRP Method Sheet)

82 | 83 Back Elecsys ® SCC NEW An important part of Roche’s portfolio in tumor markers for managing patients with squamous cell cancers

The SCC assay is used as an aid in types of lung cancer. Based on literature, the management of patients with squamous SCCA elevated serum levels were cell carcinoma in conjunction with found to be indicative of NSCLC if renal other methods that align to the standard failure and dermatological diseases ­clinical management guidelines. were excluded. Utility of SCCA in lung cancer has been also reported to ­ SCC antigen (SCCA) has been studied in its indicate disease recurrence and residual involvement in squamous cell malignancies disease following treatment and including lung, uterine cervix, esophagus, response to therapy. head & neck, anal canal and skin for many • The most common histology in cervical years. SCCA levels can be elevated in cancer is SCC, with SCCA being the squamous cell cancers and it has been biomarker of choice for this histology. ­reported that more advanced cancer stages Serum levels of SCCA have been found are associated with higher SCCA levels to correlate with tumor stage, tumor size ­especially in lung and cervical cancer. It and ­residual tumor after treatment, was reported that measurement of the recurrent or progressive disease, and Your benefit Product characteristics ­antigen, in serial determinations, aids in survival in ­patients with squamous • Combining SCC antigen with other lung • Assay time: 18 min. the assessment of disease recurrence, cell cervical ­cancer. cancer biomarkers (ProGRP, CYFRA 21-1, • Sample material: Serum, plasma residual disease following treatment, and • 90 % of head & neck cancers are NSE and CEA) gives a clearer picture on • Sample volume: 15 μL response to therapy. SCCs, in patients with primary tumors, the patient’s status • Measuring range: 0.1– 70 ng/mL SCCA serum­ levels were related to • SCC antigen as biomarker for cervical • LoQ: 0.24 ng/mL SCC antigen in different types of nodal ­involvement with significantly higher cancer is another tool in patient • Precision: < 5 % squamous cell cancers: ­levels in node-positive patients. Multi­ management together with other markers • Detection of SCC antigen 1 and 2 • SCCA has been reported as a biomarker variate analyses showed that SCCA is a for gynecological malignancies (i.e. CA • Standardization: Abbott Architect for non-small cell lung cancer significant independent predictor of 125, HE4, CA 15-3, HPV, CINtec plus) (NSCLC), mainly of the squamous disease-free­ survival and pretreatment • High assay precision for accurate and cell carcinoma type. SCC in lung levels are an independent prognostic sustainable results for patient monitoring is closely correlated with a history of ­indicator in patients with head and neck • One blood sample for all lung cancer tobacco ­smoking, more than other malignancies. ­biomarkers for time and cost efficiency • High reagent on-board stability • Short turn around time for fast results

84 | 85 Back Elecsys® Calcitonin A powerful tool for the diagnosis and monitoring www.cobas.com of medullary thyroid carcinoma (MTC)

Thyroid carcinoma is the most common Your benefit Product characteristics malignancy of the . In up A marker with high specificity • Assay time: 18 min. to 10 % of all thyroid carcinoma patients a for MTC (Figure 1) • Sample material: Serum, Li-heparin medullary thyroid carcinoma (MTC) is iden- • Sensitive tool for diagnosis and follow- ­plasma, K2-EDTA plasma, K3-EDTA plasma tified. These carcinoma produce elevated up of MTC • Sample volume: 50 μL serum concentrations of calcitonin and • High correlation with tumor burden, • LoB, LoD, LoQ*: 0.3 pg/mL, 0.5 pg/mL, therefore can be diagnosed with an excep- ­supporting early detection of new or 1 pg/mL tional degree of accuracy and specificity by ­residual disease • Measuring range: 0.5 – 2,000 pg/mL immunoassays measuring serum calcitonin. • Traceability: IRP WHO 89/620 The diagnostic marker calcitonin is a sen­ Elecsys® Calcitonin with high precision • Total imprecision: sitive and specific tumor marker for the • High sensitivity and precision at low – cobas e 411 analyzer, E2010: 2.6 – 5.2 % * LoB = Limit of Blank; LoD = Limit of Detection; ­diagnosis as well as for the life-long moni- end concentrations ensure improved – cobas e 601/e 602 modules, E170: LoQ = Limit of Quantitation with a total allowable toring of MTC patients after thyroid surgery. ­follow-up and monitoring (figure 2) 1.6 – 2.3 % error of ≤30 % • Excellent precision across the entire Elecsys® Calcitonin – excellent precision ­measuring range support accurate results Elecsys® Calcitonin – high specificity for MTC at low concentrations Cut-off Grey zone Workflow efficiency with the most 1,000,000 2% complete automated thyroid portfolio max. CV at 4.2 pg/mL 100,000 E • All tests required for differential diagnosis cs e e le of thyroid diseases are consolidated on 10,000

one platform, including routine thyroid le 11.4 % 1,000 max. CV at 22.0 pg/mL ­assays and specialties such as Elecsys lc s 13 % TgII, Elecsys Calcitonin, Elecsys Anti-Tg, 100 e max CV at 4.4 pg/mL Elecsys Anti-TPO and Elecsys Anti-TSHR 10 0 5 10 15 Elecsys essy 0 MTC MTC Apparently Apparently Thyroid Thyroid NET Malignant Graves’ Hashimoto’s (medullary recurrence healthy healthy nodules nodules (neuro- diseases disease disease Figure 2: Comparison of interassay CVs (coefficient of thyroid (n = 18) females males females males endocrine other (n = 88) (n = 138) carcinoma) (n = 193) (n = 162) (n = 147) (n = 47) tumours) than MTC variation) at the lowest ­concentrations tested. Source: (n = 15) (n = 5) (n = 14) package ­inserts; March 2013. Figure 1: Calcitonin is a highly specific marker for MTC, allowing early and specific diagnosis and reliable monitoring. Source: Performance Evaluation Study 2013, data available upon request.

86 | 87 Back Elecsys® Tg II The power to offer more for differentiated ­thyroid cancer (DTC) management

The main application for Thyroglobulin (Tg) Your benefit High quality patient results and testing is the post‑operative follow‑up of Excellent functional sensitivity accurate long-term monitoring patients with differentiated thyroid carcinoma and precision • Excellent precision across the entire (DTC). Detectable levels of serum Tg after • Improved sensitivity comes with better ­measuring range supports accurate total thyroidectomy are indicative of persis- precision in the range around the clinical results­ tent or recurrent DTC. cut-off and improved negative predictive • Lot-to-lot consistency across all cobas® value platforms allows a reliable long-term • Sensitive Tg assays can avoid TSH-­ ­patient monitoring stimulated Tg testing during follow-up • Elecsys Tg II shows lower TgAb interfer- in low-risk patients ence compared to other assays • Patients with a basal Tg below the ­functional sensitivity of a sensitive Tg Higher sensitivity allows for potentially Product characteristics ­assay have a high chance of being free earlier detection of persistence or • Assay time: 18 min.

of disease recurrence • Sample material: Serum, K2-EDTA ­plasma,

• Increasing concentrations of Tg (even K3-EDTA plasma at low concentrations) are an early and • Sample volume: 35 μL Analytical sensitivity/LoD Functional sensitivity ­reliable indicator of recurrent disease • LoB, LoD, LoQ*: 0.02 ng/mL, 0.04 ng/mL, 2nd gen. 0.05–0.1 ng/mL 1st gen. 0.5–1 ng/mL • Treatment is usually more successful 0.1 ng/mL ce Elecsys 0.04 0.09 with early detection as the tumor burden • Measuring range: 0.04 – 500 ng/mL ees le 0.2 0.9 is lower • Traceability: BCR-CRM 457 e ccess 0.1 • Total imprecision: 0.2 – cobas e 411 analyzer, E2010: 2.6 – 9.2 % y 0.17 0.5 – cobas e 601/e 602 modules: 4.0 – 5.9 % cc ls 0.09 0.15 0.01 0.1 1 cce

Sensitivity of current automated Tg assays: Elecsys Tg II with best-in-class sensitivity. Source: Package inserts, Feb. 2013.

* LoB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation with a total allowable error of ≤20 %.

88 | 89 Back Elecsys® Anti-TSHR Complex testing simplified and automated www.cobas.com

Elecsys Anti-TSHR (TRAK) is a fully auto- Your benefit Product characteristics mated test for detection of autoantibodies Improved efficiency • Assay time: 27 min. to the TSH receptor. • Fully automated test for more workflow • Sample volume: 50 µL efficiency, allows for consolidation of tests • Measuring range: 0.3 – 40 IU/L Clinical utility: required for differential diagnosis of • Functional sensitivity: 0.9 IU/L • Detection or exclusion of Graves’ auto- thyroid­ diseases • Cut-off: 1.75 IU/L immune hyperthyroidism and differentia- • Rapid availability of Anti-TSHR results • Precision: < 6 % tion from disseminated autonomy of the supports cost- and time-efficient differen- • Strong discrimination between positive thyroid gland (figure 1) tial diagnosis of thyroid diseases and and negative results • Monitoring therapy and prediction early­ treatment • Standardization: NIBSC 1st IS 90/672 of relapse • Assessing the risk of developing fetal High quality results High clinical accuracy of Elecsys® The clinical study comprised: ­hyperthyroidism in the last trimester of • Advanced assay quality based on proven Anti-TSHR • 436 samples from apparently healthy

pregnancy and leading ECL technology 1 individuals • Excellent precision across the entire 0.9 • 210 patients with thyroid diseases ­measuring range (figure 2) 0.8 excluding Grave's disease • High diagnostic value based on high 0.7 • 102 patients with untreated Grave’s disease ­sensitivity paired with high specificity 0.6 rea nder cre 0.5 Using a cutoff of 1.75 IU/L a clinical sensitivity of 97 % and a specificity of 9 %

35 esy 0.4 30 0.3 was obtained. 25 0.2 FS (CV 20 %): 0.73 IU/L 20 0.1 15 0 Cut-off limit 1.75 IU/L: CV 11 % 0 0.2 0.4 0.6 0.8 1 10 eccy Hermsen, D. et al. (2009). Technical evaluation of the 5 first fully automated assay for the detection of TSH 0 Figure 1: Clinical accuracy of Elecsys Anti-TSHR. receptor autoantibodies. Clin Chim Acta, 84 – 89. 0 1 2 3 4 5 6 7 8 910 11 12 13 14 15 16 17 18 19 20 e les

Figure 2: The functional sensitivity of Elecsys Anti-TSHR at approx. 0.9 IU/L is significantly below the cut-off (≥1.75 IU/L), allowing clear differentiation of pathological results.

90 | 91 Back Elecsys® Vitamin D total Allowing better patient care with results www.cobas.com you can trust

Vitamin D has a proven impact on bone Your benefit Product characteristics Proven accuracy with certified Vitamin D mineral density and bone quality. Desirable • Standardized against LC-MS/MS (traceable • Assay time: 27 min. Reference Panel levels of 30 ng/mL have been shown to to NIST) for confidence in patient results • Sample material: Serum and plasma 80% ­reduce the risk of falls and fractures. • High lot-to-lot consistency for optimal • Sample volume: 15 μL 60% therapy monitoring • Functional sensitivity: 4.01 ng/mL 40%

There is also growing scientific evidence • Excellent functional sensitivity and superior (10.0 nmol/L) (CV 18.5 %) e le 20% linking the level of vitamin D (25-OH) to an precision over the clinically relevant range • Repeatability: Within-run precision: 0% 3.9% increased risk of other indications such as • Efficiency due to consolidation of Vitamin D <15 ng/mL: SD ≤ 1 ng/mL, -20% diabetes, cardiovascular disease, autoimmune total, b-CrossLaps, P1NP, Osteocalcin and >15 ng/mL: ≤ 6.5 % -40% le eece diseases, and different forms of cancer. PTH testing on one fully automated platform • Reproducibility: Intermediate precision: -60% Elecsyse le The Elecsys Vitamin D total assay aids in <15 ng/mL: SD ≤1.7 ng/mL, -80% 0 50 100 150 the assessment of vitamin D sufficiency. >15 ng/mL: ≤11.5 % l Traceability and standardization Assessment of Vitamin D Reference Panel, certified by National Institute of Standards & Technology (NIST) University of Ghent LC-MS/MS reference measurement Standard reference material (SRM) 2972 procedure. Ethanolic solutions of vitamin D2 (25-OH) and vitamin D3 (25-OH) Consistent results from lot to lot SRM 972 80 Four levels of serum with different concentrations of vitamin D (25-OH), value assignment by LC-MS/MS 70 64.2 60 50 LC-MS/MS 40 Liquid chromatography tandem mass spectrometry NIST SRM2972 used for calibration, NIST SRM972 30 for quality control l 20 20.9 10 0 Elecsys Vitamin D total 23.5.12 12.7.12 31.8.12 20.10.12 9.12.12 28.1.13 19.3.13 8.5.13 27.6.13 Fully automated protein binding assay e calibrators based on serum matrix, standardization against LC-MS/MS Long-term recovery of serum pools over 4 different reagent lots.

Wielders et al. (2014). J Clin Lab Anal, Epub ahead of print DOI 10.1002/jcla.21793.

92 | 93 Back Elecsys® Anti-Mullerian Hormone (AMH) Providing clinical confidence in the assessment www.cobas.com of ovarian reserve

Mean female age at first birth has in- Your benefit Precision and sensitivity creased steadily over the past few decades • Fully automated, fast, sensitive and robust Elecsys® AMH Manual method in many developed countries. This post- measurement of AMH 100 ponement leads to couples attempting to • High precision over entire measuring 80 60

have children during a period where female range for reliable results 40 fertility is already in decline. 30 % of infer- • Clinical agreement with Antral-Follicle- 20 tility problems among women arise from Count (AFC) 0 diminished ovarian reserve. • Age specific reference ranges and PCOS 0.23 ng/mL 0.79 ng/mL 0.96 ng/mL 2.73 ng/mL 4.92 ng/mL 13.6 ng/mL 17.96 ng/mL HSP 1 HSP 2 PC AMH 1 HSP 3 PC AMH 2 HSP 4 HSP 5 (polycystic ovary syndrome) information ce Anti-Mullerian hormone (AMH) is a Figure 1: Precision comparison between Elecsys and a manual method on the market as part of a method comparison direct serum marker of functional ovarian Product characteristics study conducted. The study has been run according to CLSI Protocol (CLSI-EP5). reserve and plays an important role in • Assay time: 18 min. HSP – Human Serum Pool, PC AMH – PreciControl AMH assessing ovarian reserve levels and • Traceability: Standardized against BCI therefore the capacity to provide eggs AMH Gen II ELISA (unmodified) Agreement and low variability in results vs. AFC for fertilization. • Sample material: Serum and Li-heparin AMH (ng/mL) AFC N=37 N=55 N=59 N=111 N=57 N=115 N=17 plasma 45 15

40 AMH assists in assessment of ovarian • Sample volume: 50 μL 35 30 10 reserve, for example identifying in patients • LoB, LoD, LoQ*: 0.007 ng/mL, 25 20 at risk of having diminished ovarian reserve. (0.05 pmol/L), 0.010 ng/mL, 15 5 10 AMH can also add prognostic information (0.071 pmol/L), 0.030 ng/mL, 5 0 0 to the counseling and planning process for (0.214 pmol/L) Site 1 Site 2 Site 3 Site 4 Site 5 Site 6 Site 7 infertile couples seeking treatment. • Measuring range: 0.01 – 23 ng/mL Figure 2: Distribution of AFC and AMH in 7 site multicenter evaluation. Multiple technicians performed AFC (0.071 – 164.2 pmol/L) at each site. There is also growing scientific evidence • Intermediate imprecision: linking between the level of AMH and Poly- – cobas e 411 analyzer: 2.9 – 4.4 % cystic ovary syndrome (PCOS), prediction – cobas e 601/e 602 modules: 2.7 – 3.5 % of time to menopause, disorders of sex de- – Lowest conc. measured: 0.232 ng/mL velopment in children, and ovarian function in cancer patients under chemotherapy.

* LoB = Limit of Blank, LoD = Limit of Detection, LoQ = Limit of Quantitation

94 | 95 Back Elecsys® sFlt-1/PlGF Short term prediction and diagnosis www.cobas.com of preeclampsia

Preeclampsia is a serious multi-system Your benefit Product characteristics complication of pregnancy, occurring in • Elecsys sFlt-1 and PlGF immunoassays Technical assay features on Elecsys® sFlt-1 and PIGF 3 – 5 % of pregnancies, and it is one of the for preeclampsia are the first available sFlt-1 PlGF leading causes of maternal and perinatal and approved automated diagnostic Assay time 18 min. morbidity and mortality worldwide. tests for fast and easy assessment in a Sample material Serum clinical context Sample volume 20 μL 50 μL Preeclampsia is defined as new-onset of • The measurement of the Elecsys sFlt-1/ Measuring range 10– 85,000 pg/mL 3 –10,000 pg/mL hypertension and proteinuria after 20 weeks PlGF ratio is a reliable tool to identify the of gestation. The clinical presentation of patients that are at high risk to develop The Elecsys sFlt-1/PlGF ratio can improve the management of suspected preeclampsia preeclampsia and subsequent clinical course preeclampsia requiring a closer monitoring patients allowing short-term prediction and diagnosis. An improved prediction and diagnosis of the disease can vary tremendously, making and to confidently send home patients that of preeclampsia can allow a reduction of inappropriate discharges as well as a reduction prediction, diagnosis and assessment of are not going to develop the disease of unnecessary hospitalizations, therefore a reduction of the health care burden. disease progression difficult. • Early and precise diagnosis of pre- eclampsia leads to effective clinical Early onset preeclampsia – Late onset preeclampsia – gestational week 20 – 34 gestational week 34 to end of pregnancy Angiogenic factors (sFlt-1 and PlGF) are management and improves the outcome proven to play an important role in the for both mother and child sFIt-1/ Diagnosis 99.4 % specificity sFIt-1/ Diagnosis 95.5 % specificity PIGF the patient has PIGF the patient has pathogenesis of preeclampsia and their ≥ 85 preeclampsia ≥ 110 preeclampsia concentrations in maternal serum are Sensitivity: 88.0 % Sensitivity: 58.2 % altered even before the onset of the disease sFIt-1/ Prediction 38.6 % PPV sFIt-1/ Prediction 38.6 % PPV PIGF rule-in the patient is at PIGF rule-in the patient is at making them a tool for prediction and < 85 in the next high risk to develop < 110 in the next high risk to develop diagnosis of preeclampsia. ≥ 38 4 weeks preeclampsia within ≥ 38 4 weeks preeclampsia within the next 4 weeks the next 4 weeks sFIt-1/ Prediction 99.1 % NPV sFIt-1/ Prediction 99.1 % NPV PIGF rule-out the patient will PIGF rule-out the patient will < 38 for the next not develop < 38 for the next not develop 1 week preeclampsia in 1 week preeclampsia in the next 1 week the next 1 week

Verlohren, S., Herraiz, I., Lapaire, O., Schlembach, D., Moertl, et al. (2012). Am J Obstet Gynecol. 206(1),58.e1– 8. Verlohren, S., Herraiz, I., Lapaire, O., Schlembach, D., Zeisler, H., et al. (2014). Hypertension. 63(2),346–352. Schnettler, W.T., Dukhovny, D., Wenger, J., Salahuddin, S., Ralston, S.J., Rana S. (2013). BJOG 120(10),1224–123.

96 | 97 Back Tina-quant® Hemoglobin A1c Efficiency for the diagnosis and monitoring www.cobas.com of diabetes

HbA1c is viewed as a significant and Your benefit Product characteristics ­accepted diabetic marker. For most people One test for diagnosis and monitoring • Twin test reaction technology with diabetes, the target HbA1c is below • First HbA1c assay on the market that can • Reagent lot-specific calibration 48 mmol/mol (6.5 % HbA1c), since evidence be used for the diagnosis of diabetes and • NGSP certified and traceable to the IFCC shows that this can reduce the risk of to identify persons at risk of developing and DCCT reference method ­developing diabetic complications. diabetes, and for monitoring (FDA/CE) • Dual reporting in mmol/mol and % • Intermediate precision (CV) <1.5 % In 2009 an international expert committee Reliable diabetes management • Whole blood and hemolysate application recommended HbA1c as a test for the diag- • With excellent precision and accuracy • 70 % immersion depth into the primary nosis of type 2 diabetes and prediabetes. tube for correct and reproducible recovery The Tina-quant assay provides a fast and Uncompromised performance of fast settling whole blood samples precise routine­ HbA1c measurement for • With no interference from HbAS, • FDA approved/CE the comprehensive care of your diabetes HbAD, HbAD and HbAE or acetylated, patient. carbamylated Hb and labile HbA1c

Glucose l s e l Efficiency, cost and workflow ­improvements • Easy integration into routine testing for Epitope of Roche antibody efficiency, cost and workflow improve- Glycated (HbA1c) N-terminal hexapeptide and ments. Without post-analytical data epitope recognition of the Roche HbA1c antibody for ­review (e.g. interpretation of chromato- measuring the “true” HbA1c as defined by the IFCC grams) reference system.

98 | 99 Back The full SWA immunosuppressive NEW drug assay panel www.cobas.com Trusted and consistent results for organ transplant patients

Optimal immunosuppressive therapy, Your benefit Consistent results for life-long ­defined clinically and by therapeutic drug Consolidation for optimized workflow ­monitoring monitoring (TDM), is essential to prevent The new Elecsys Sirolimus and Everolimus • Excellent lot-to-lot comparability and acute rejection and ensure long-term survival assay complete the ISD menu and are an traceability of both the patient and the allograft. Char- important addition to the cobas TDM • Consistent patient results across all acterized by a narrow therapeutic window, menu making it the most complete ISD ­cobas® platforms due to universal the use of immunosuppressive drugs product offering. ­reagent concept (ISDs) requires both precise and consistent • The full ISD menu now available on one • Low variability across different customer measurement of their concentration in automated and integrated Roche SWA labs proven in external quality schemes whole blood during life-long monitoring. platform: • High comparability to well established – Best-in-class automated MPA available and validated LC-MS/MS on cobas c modules – Elecsys Cyclosporine and Tacolimus N = 1029 samples, Weighted Deming Regression now completed with Sirolimus and Product characteristics y = 1,07 x – 0,269, r = 0,97 Everolimus on cobas e modules Tacrolimus Cyclosporine Sirolimus Everolimus Kidney Liver Heart Unknown • One universal pre-treatment procedure Assay time 18 min. 40 for all ISD assays increase efficiency, en- Sample material EDTA whole blood sure high quality results for every product Sample volume 300 µL 30 and reduce handling errors in the lab Sample pretreatment Identical sample pretreatment • Outstanding possibilities for consolidation Sensitivity LoB * 0.3 ng/ml 20 ng/mL 0.4 ng/mL 0.4 ng/mL 20 with >230 parameters on one cobas® LoD * 0.5 ng/mL 30 ng/mL 0.5 ng/mL 0.5 ng/mL platform LoQ * 1.0 ng/mL 50 ng/mL 1.5 ng/mL 1.0 ng/mL

cs Measuring range 0.5 – 40 ng/mL 30 – 2,000 ng/mL 0.5 – 30 ng/mL 0.5 – 30 ng/mL 10 Total imprecision High precision for confidence cobas e 411 analyzer 2.1–14.2 % 4.2 – 9.2 % 2.8 – 10.9 % 2.7 – 8.1 % 0 in results cobas e 601/e 602 modules 2.4 –10.4 % 3.1– 6.4 % 3.4 – 9.5 % 3.9 – 6.7 % 0 10 20 30 40 • High precision at low drug concentrations  * L oB = Limit of Blank; LoD = Limit of Detection; LoQ = Limit of Quantitation and across a wide measuring range Elecsys® Tacrolimus: excellent correlation with a well evaluated LC-MS/MS. (Source: Multicenter evaluation • Superior performance confirmed in study 2013) ­routine customer laboratories

100 | 101 Back

Hemostasis testing

Roche is moving towards a comprehensive The cobas t 411 coagulation analyzer is Platelet function testing new hemostasis testing portfolio with a the recent addition to Roche’s Hemostasis number of industry firsts and innovative portfolio. It serves low- to medium-volume Hemostasis applications for early disease detection central coagulation laboratories. Featuring and monitoring. From easy-to-use, low- innovative sample and reagent management volume analyzers for self- and professional concepts, It enables increased operator Coagulation monitoring, to systems meeting the high convenience and productivity. efficiency requirements of the laboratory, Laboratories Roche’s products provide the highest quality The coagulation portfolio will be expanded results, offering outstanding productivity by instruments that will serve the medium- Multiplate while reducing complexity. to high-volume laboratories and for which connectivity to Roche’s automation line will Like Roche’s current instruments, the new be available. generation of testing solutions is driven by a commitment to deliver high-quality, cost- The new coagulation analyzers, combined effective solutions capable of addressing with the point-of-care meters, the the current and future testing needs of a Multiplate® analyzer and the LightCycler® wide range of customers. for genetic hemostasis testing will allow Roche to provide a full portfolio of solutions for primary and secondary hemostasis testing.

For more information please visit www.cobas.com and www.roche-multiplate.com

102 | 103 Back cobas t 411 coagulation analyzer NEW For maximum efficiency www.cobas.com

The cobas t 411 coagulation analyzer is Your benefit Premium safety the powerful first member of the new Ease-of-use • Automated multi-vendor cap-piercing coagulation family of products designed for • High reagent, sample and cuvette storage • Positive sample management via the the low to medium throughput laboratory. capacity requires minimal interaction integrated automatic barcode scanner during daily use • Patient results are fully traceable The cobas t 411 analyzer is ideally suited for • Start mechanism via one button start maximum efficiency and flexibility supported system Product characteristics by innovative features like automated, multi- Throughput vendor cap-piercing and integrated barcode Dynamic workflow • Up to 140 tests/hour (PT) scanning for samples and reagents. • Continuous loading • Up to 100 tests/hour (mixed mode) • Large onboard storage capacity, walk- Featuring continuous loading of reagents, away time is maximized and hands-on Samples samples and cuvettes, the cobas t 411 time minimized • Up to 100 samples on-board analyzer ensures maximum productivity • Dedicated STAT port • Cap-piercing and dynamic workflow. • Dedicated STAT port • Continuous loading via 5 position racks

Reagents • Continuous rack-based loading • Up to 70 vials on-board capacity • Extended Routine Menu inlcuding PT, APTT, FIB, TT, AT and DD

Test principle Software • Unique opto-mechanical measuring • Comprehensive QC program including principle Levey-Jennings • Clotting, chromogenic, immuno- • User-definable protocols turbidimetric assays • LIS connectivity

cobas t 411 coagulation analyzer

104 | 105 Back Multiplate® analyzer Platelet function testing with best-in-class www.roche-multiplate.com predictivity­

Blood platelets play a pivotal role in physi- have a 5 –10 fold increased risk of stent Your benefit Consistent results ological hemostasis, but also in the devel- thrombosis, stroke and myocardial infarc- Cost-effective therapies • using standardized reagents and opment of arterial thrombosis (myocardial tion1-4 following percutaneous coronary • in cardiac surgery10 ­procedures infarction and stroke). Platelet function ­interventions. Multiplate delivers best-in- • in coronary interventions11 testing is utilized in the analysis of inherited class predictivity5 and evidence is available Medical momentum and acquired platelet function disorders demonstrating that Multiplate guided anti- Fast and easy assessment • More than 400 Medline publications, that may cause a transient or permanent platelet therapy has the potential to improve • of platelet function from small volumes ­consensus papers with Multiplate and bleeding tendency. The Multiplate analyzer patient outcome.6-8 of whole blood published guidelines for PFT can detect platelet dysfunction and thus aid in the therapeutic management of such The Multiplate analyzer also plays a role in Best predictivity Product characteristics patients. the analysis of platelet function in anesthesia • for stratification of bleeding risk in • High throughput: 30 tests/hour and intensive care, where platelet dysfunc- ­surgical procedures • Sample volume: only 300 μL per analysis It can also be used for monitoring of anti- tion can lead to severe bleeding complica- • for tailored anti-platelet therapy • Fast turn-around time: 10 min./test platelet drugs where both compliance and tions. The detection or exclusion of platelet drug effectiveness are key issues. It was dysfunction before invasive procedures Comprehensive reagent menu of CE marked tests and controls shown with Multiplate results1 that up to or in bleeding patients can aid the risk 20 % of patients do not respond adequately stratification and management in these Products Description 9-10 ADPtest ADP induced platelet activation sensitive to clopidogrel, prasugrel and other ADP to clopidogrel treatment. These patients situations.­ receptor antagonists ASPItest Cyclooxygenase dependent aggregation (using arachidonic acid) sensitive to 1 Sibbing, D. et al. (2009). J Am Coll Cardiol. Mar 10; Aspirin®, NSAIDs and other inhibitors of platelet cyclooxygenase 53(10):849-56. COLtest Collagen induced aggregation 2 Sibbing, D. et al. (2010). Thromb Haemost. Jan; 103(1):151-9. RISTOtest vWF and GpIb dependent aggregation (using ristocetin) 3 Schulz, S. et al. (2010). Am Heart J. Aug; 160(2):355-61. TRAPtest Platelet stimulation via the thrombin receptor (using TRAP-6), sensitive to IIbIIIa 4 Siller-Matula, J.M. et al. (2010). J Thromb Haemost. Feb; receptor antagonists 8(2):351-9. Prostaglandin E1 reagent For the assessment of ADPtest HS (high sensitivity). For the assessment of positive 5 Bonello, L. et al. (2010). J Am Coll Cardiol. Sep 14; (i.e. abnormal) controls of the ADPtest 56(12):919-33. ASA reagent Inhibitor of cyclooxygenase. Addition of ASA reagent to the blood sample leads to 6 Siller-Matula, J.M. et al. (2013). Int J Cardiol. Sep 1; 167(5): reduced aggregation responses in ASPItest and COLtest 2018-2023. GpIIb/IIIa antagonist reagent Inhibitor of the platelet GpIIb/IIIa receptor. Addition to a blood sample leads to 7 Sibbing, D. et al. (2012). J Am Coll Cardiol. 59; E265. strongly reduced aggregation in the TRAPtest 8 Aradi et al. (2013). J Am Coll Cardiol. 61(10): E1922. Hirudin blood tubes Anticoagulant for platelet function analysis with physiological calcium 9 Ranucci, M. et al. (2011). Ann Thorac Surg. Jan; 91(1):123-9. concentrations­ 10 Weber, C.F. et al. (2012). Anesthesiology, Sep; 117(3):531-47. 11 Straub, N. et al. (2013). Thromb Haemost. Oct 24; 111(2). Liquid control set Quality control for electrical signal in impedance aggregometry based on the analysis of an artificial liquid control material [Epub ahead of print]

106 | 107 Back

Urinalysis

Urinalysis has always been an important Today Roche offers a broad portfolio of Combur ­diagnostic tool in medicine. Even today, ­urinalysis solutions for different customer urine is still a key health barometer for needs. Drawing on our 50 years of experi- Laboratories many diseases, mainly urinary tract infec- ence in urinalysis, starting with the launch tions, kidney disease and diabetes. The of the first Combur-Test ® strip, we have analysis of urine can reveal serious diseases continuously improved strip technology for Sediment that show no symptoms in their early stages clinical and general practice. In response but are treatable. These diseases can cause to customer needs for increased efficiency Urine work area solution severe damage if they remain undetected. and safety, we have developed a range Urine test strips are a crucial diagnostic of analyzers with differing degrees of Point of Care tool and easy to use, yielding quick and automation and throughput capabilities. reliable information on pathological changes By combining the proven Combur-Test strip in the urine. Their diagnostic significance technology with Roche automation, we Physician’s office lies primarily in first-line diagnosis, screening offer customized urinalysis solutions for during routine or preventive examinations, physician office laboratories, hospital point- 50 years experience and treatment monitoring. of-care and central laboratory settings.

For more information please visit www.cobas.com

108 | 109 Back Urinalysis from Roche Micral-Test ® strip for albumin in urine Expertise coming from a long tradition Quick and secure results of albumin of more than 50 years in urine

www.cobas.com

The Micral-Test is an easy to use test Fast and easy designed to deliver quick and secure results, After 60 seconds, result is ready for visual specific for human albumin and sensitive reading with a convenient color comparison across the diagnostic range. Using one test on the strip box. The Micral-Test is easy to for all patient groups, the Micral-Test is a handle and improves testing workflow. cost efficient way to gain actionable health Micral-Test ® Combur-Test ® cobas u pack Urisys 1100 ® information. Unique design of the Micral-Test strip delivers secure results Your benefit • The Immunological test principle with Specific for human albumin monoclonal antibodies is highly specific The Micral-Test is based on an immuno­ for human albumin logical test principle using gold-labelled • The urine sample is absorbed by the test monoclonal antibodies with a chromo­- strip and transferred through the genic color indicator ensuring confidence following two zones before reaching the Sediment terminal cobas u 411 urine analyzer cobas ® 6500 urine analyzer series in results. detection pad: Zone 1 – Conjugate Fleece contains free Urine diagnostics portfolio Sensitive across the diagnostic range gold-labelled antibodies The cutoff for positive results is 20 mg/L Zone 2 – Capture Matrix Fleece with fixed Micral-Test ® Combur-Test ® Urisys 1100 ® cobas u 411 cobas 6500 urine urine analyzer analyzer series with an excellent sensitivity of 97 %. The (HSA) Automation Visual reading strip Visual reading and Instrument Semi-automated Fully automated Micral-Test does not show a “hook-effect” grade for microalbumin for all UA platforms intended for single urinalysis system urine work area measurements for small to solution for large- because it uses a chromogenic color in wards or in medium sized scale laboratories reaction instead of an agglutination reaction. physicians’ offices laboratories Workloads Manual Manual 10 – 50 samples 30 –100 samples 100 –1,000 samples per day per day per day Wick fleece Zone 1: Detection pad Test strips Micral-Test Combur 2,3,4,5,6,7,9,10 Combur 10 Test UX Combur 10 Test M cobas u pack Conjugate Test Combur 5 Test Matrix Fleece Combur 7 Test Consumables cobas u cuvette

Zone 2: Capture Sample level Matrix Fleece Carrier foil

110 | 111 Back Combur-Test ® strip Urisys 1100 ® analyzer Established quality – proven to perform Small and easy

Urine reagent strips are a useful tool for • Test area colors prevented from flowing The Urisys 1100 analyzer is a small semi- Your benefit ­investigating, diagnosing and screening with an absorbent paper automated benchtop instrument for a Compact diseases immediately. Reliable and precise • Reduction of the risk of false results ­workload of 10 to 50 samples per day. It is • Semi-automated urine analyzer for the results are important, since adulterated through compensation of strong intrinsic optimal for small labs, doctor’s offices or small lab, ward or doctor’s office ­results can lead to false negative results urine coloration with the availability of a in decentralized settings. or re-testing of patients. Roche’s unique color compensation pad* Easy handling test strip technology is used for visual test The high quality Combur-Test ® strips • Automatic printing of results strips and for all instrument test strips. Easy strip handling ­provide accurate results in one minute • Facilitation of analysis with a consistent which can be optionally printed out for Simplify your life Your benefit reading time of 60 seconds for all your convenient documentation. • Eliminate manual documentation through Accuracy parameters­ the export of data via host connection • Combur-Test ® strip * detects even low • Advanced and hygienic strip handling concentrations of glucose and erythro- with possibility of reading tip down Safety cytes/hemoglobin (5 – 10 Ery/mL) in the • Prevent unauthorized access and comply presence of vitamin C with accreditation requirements via an pH LEU NIT PRO KET SG UBG BIL GLU ERY/Hb COMP operator lock-out feature Efficiency • Avoidance of retesting and false-negative Product characteristics results in glucose and blood even Diazonium • Workloads: 10 – 50 samples per day salt Iodate with high levels of ascorbic acid (up to Nylon impregnated impregnated • Throughput: approx. 50 test strips/hour 400 mg/L) with the application of an mesh mesh mesh • Combur-Test ® is resistant to ascorbic iodate impregnated mesh layer acid interference Plastic Absorbent carrier foil paper • Control-Test M for weekly calibration Safety • Test strips *: Combur 10 Test ® UX Combur-Test urine test strips from Roche have • Independence interference from of • Memory capacity: 100 results iodate impregnated mesh layers and are uninfluenced glued components as a result of a unique by ascorbic acid. • Printer: Thermal printer sealing technology * For instrument tests only. • Connectivity to the cobas POC IT solution

* Combur 7 Test ®, Combur5Test ® are not available in all countries.

112 | 113 Back cobas u 411 urine analyzer Consolidated result management www.cobas.com

The cobas u 411 semi-automated urine Your benefit Product characteristics ­analyzer is designed for workloads of Fast and efficient workflow • Workloads: 30 – 100 samples per day ­approximately 30 –100 samples per day. • By connecting analyzer to sediment • Throughput: 600 tests/hour ­terminal and consolidating the results • Continuous loading of test strips without When connected to the optional barcode ­requiring a measurement cycle reader and sediment terminal, this analyzer Ensure reliable results – optional barcode reader simplifies designed optimized work and data flow. • Ascorbic acid does not interfere with ­manual work steps test strips • Entry of tracking information ­including user identification and lot numbers­ for test Safe and hygienic handling of strips strips, calibration strips and control material • Due to netsealing technology Consolidated analysis Parallel working on the cobas u 411 analyzer and its connected sediment terminal as a result of a consolidated work and data flow for strip analysis and microscopy. Easier documentation and improved overview of patient records with single print-out for strip and microscopic information.

ae int oa of irooi ret Work list via LIS, barcode scanner or manual input

Conoiate ret ne orae Upload to LIS/Host or Microscopic examination print out in one single record and input via keypad

et onoa Display of sample ID + test strip

cobas u 411 urine analyzer Semi-automated urine work area solution.

114 | 115 Back cobas ® 6500 urine analyzer series One tube, one touch – fully automated www.cobas.com urine workflow

The cobas 6500 urine analyzer series is a Precise and safe strip results Product characteristics fully automated urine work area solution for • High quality results by proven unique strip cobas u 601 urine analyzer laboratories processing 100 – 1,000 urine construction based on 50 years experience • Fully automated urine strip new generation samples per day. • Accurate, safe results by new technology • 12 on-board parameters • Throughput: 240 samples/hour Due to its modular design cobas 6500 Consolidation of urine work area • cobas u pack; urine ­analyzer series can be installed as a • Convenient validation – – cassette with 400 test strips stand-alone urine analyzer or as a stand- all results on one screen – Combur-Test ® strips cobas u 601 urine analyzer alone microscopy­ analyzer or together as a • Full menu covers urine strip testing – two weeks on-board stability fully automated urine work area. and urine sedimentation (humidity protected) • New photometer technology for the strip Your benefit Workflow optimization result reading Automation of the gold standard • Full integration into lab automation • Detecting the intact and lysed erythrocytes • Taking real microscopy images – elimi­ nating operator variability and the need cobas u 701 microscopy analyzer

for manual review, improving TAT • Fully automated urine microscopy system cobas u 701 microscopy analyzer • 11 on-board parameters • Reagent-free system • Throughput: 116 samples/hour • 400 cuvettes in one package (cobas u cuvette) • Excellent counting performance • Storage of real images cobas 6500 urine analyzer series

cobas® connection module (CCM) connected to 2 cobas 8000, cobas p 501 post-analytical unit, cobas 6500 and cobas u 601

116 | 117 Back

Molecular diagnostics

Roche is a pioneer in molecular diagnos- to identify the molecular characteristics Real-time PCR tics. Since 1992 we have been providing of ­patients and diseases, thus enabling ­innovative tests based on the Nobel Personalized Healthcare. Virology ­Prize-winning polymerase chain reaction (PCR) technology. Roche products also help to ensure the safety of blood and blood products Women’s health Thanks to our wide range of products, by ­using Roche Molecular Diagnostics ­services and solutions we are able to cover ­approved systems to screen donations. Genomics/Oncology the needs of different types of hospitals and laboratories worldwide. Besides molecular diagnostic solutions, Full automation we also provide a range of innovative Roche provides solutions for indication ­products for nucleic acid purification and ­areas such as hepatitis, HIV, transplantation, PCR in the field of molecular biology. Blood screening women’s health, oncology, genomics and microbiology. We have recently expanded For more information please Microbiology molecular testing point of care segment to visit www.molecular.roche.com better serve customers needs with after- hours and STAT testing within the primary Companion diagnostics care segment. These solutions are designed to provide information that allows health- Molecular Point of Care care professionals to diagnose diseases and monitor patients’ response to therapy. In addition we offer a range of products

118 | 119 Back Molecular diagnostics solutions Innovative, reliable and efficient www.molecular.roche.com

Meeting the requirements for confidence in Your benefit Laboratory needs • Medium throughput Manual or COBAS® AmpliPrep Instrument COBAS® TaqMan® 48 Analyzer PCR results and comprehensive high- • Flexible, efficient workflow Manual low throughput quality solutions, Roche offers a wide range • Innovative real-time PCR technology meets solution available with COBAS® TaqMan® 48 of systems including full lab automation international guidelines for sensitivity and Analyzer for unrivalled efficiency, integrated IVD and linear measurement range • Very low throughput cobas® Liat System LDT processing for greater consolidation, • Confidence in results due to integrated On-demand testing for the Point of Care and connectivity to pre- and post-analytics. quality controls and physical and ­biochemical contamination control

Blood and Donor Screening Systems Workflow solutions for molecular diagnostics • Very high throughput cobas® 6800/8800 Systems and cobas p 680 Instrument • Absolute automation Laboratory needs • Unmatched flexibility IVD Systems • Very high throughput cobas® 8800 System • Absolute automation • High throughput cobas s 201 System • Unmatched flexibility

• Mid-high throughput cobas® 6800 System • Absolute automation • Unmatched flexibility LDT Solutions • High throughput FLOW Solution • Complete Workflow • Mid to low throughput cobas® 4800 System • Full automation cobas z 480 Analyzer available as standalone ­solution with manual Roche Primary MagNA Roche PCR Roche PCR sample prep for oncology Sample Handling Pure 96 Set-up Instrument

cobas x 480 Instrument cobas z 480 Analyzer • Medium and low High Pure or MagNA Pure LC 2.0 Systems LightCycler® 96 or 480 System • Mid to low throughput COBAS® AmpliPrep/COBAS® TaqMan® System throughput • Full automation

120 | 121 Back Test Overview ® ® 480 480 z z ® ®

TaqMan TaqMan

6800/8800 4800, 6800/8800 4800, Liat System Liat System Liat ® ® ® ® ® ® ® ® ® ® Detection cobas cobas LightCycler Detection cobas cobas LightCycler cobas s 201 cobas cobas x 480/ cobas s 201 cobas cobas x 480/ COBAS COBAS AMPLICOR COBAS AMPLICOR COBAS Viruses Sepsis pathogens Cytomegalovirus Quant. • • /Fungi Qual., Diff. • Hepatitis B Quant. ••• Bacteria/Fungi Qual., Ident. • Hepatitis C quant Quant. ••• Blood screening Hepatitis C qual Qual. • MPX: HIV-1 **, HIV-2, HCV, HBV Qual., Diff. •• Hepatitis C GT Genot. • * •• DPX: B19V/HAV Qual., Diff. •• Herpes Qual., Diff. • • West Nile virus Qual. •• Human Immunodeficiency Quant. ••• Hepatitis E Qual. • Human Immunodeficiency Qual. • * • Bacteria Human Immunodeficiency RUO Qual. • Strep A Qual. • Human Papillomavirus Qual., Genot. • * • Oncology Influenza A/B Qual., Diff. • BRAF Qual., Mut. Detect. • Influenza A/B+RSV Qual., Diff. • BRAF/NRAS (LSR) Qual., Mut. Detect. • * Parvo B 19 (RUO) Quant. • KRAS Qual., Mut. Detect. • Varicella-Zoster Qual. • KRAS V2 (LSR) Qual., Mut. Detect. • * Other pathogens EGFR V2 Qual., Mut. Detect. • Chlamydia trachomatis/Neisseria gonorrhoeae Qual. • * •• PIK3CA (RUO) Qual., Ident. • Chlamydia trachomatis Qual. • BCR-ABL (RUO) Quant. Relative • Chlostridium difficile Qual. • • * Genetics Methyllicin resistant staphylococcus aureus Qual., Diff. • • * • Factor V Leiden Qual., Mut. Detect. • * • Mycobacteria Tuberculosis Qual. • * • Factor II Qual., Mut. Detect. • * • Trichonomas vaginalis/Mycoplasma genitalis Qual. • * HLA-B * 5701 Qual. • Vancomycin resistant enterococcus Qual. • Qual. = Qualitative; Quant. = Quantitative; Genot. = Genotyping; Diff. = Differentiation; Ident. = identification; Mut. Detect. = Mutation Detection * In development. ** Groups M and O. RUO = For research use only. Not for use in diagnostic procedures. Please check with your local Roche representative on availability of the assays and tests in your country. LSR = Life Science Research

122 | 123 Back cobas® HPV Test Know the risk www.hpv16and18.com

Almost all cervical cancer is attributable Your benefit Product characteristics Test principle: to HPV, so knowing a woman’s HPV Evidence based Coverage: • Multiplex assay to detect 12 pooled status is important to ascertain her risk • Clinically validated in Roche’s landmark • Identifies (types) HPV 16 and HPV 18 high risk genotypes, with simultaneous of cervical cancer and to determine ATHENA trial, the largest U.S.-based regis- while concurrently detecting the rest of individual genotyping for highest risk clinical management. tration study for cervical cancer screening, the high risk types (31, 33, 35, 39, 45, 51, HPV 16 and 18 including more than 47,000 women 52, 56, 58, 59, 66 and 68) at clinically • Beta-globin acts as control for extraction The cobas 4800 HPV Test is the only • One in 10 women in the landmark ATHENA ­relevant infection levels and amplification ­clinically validated CE-marked, and FDA- study who tested positive for either HPV approved assay for first-line, primary genotype 16 or 18 had evidence of cervical Sample material: Throughput: screening of cervical cancer, that simulta- pre-cancer, even though their Pap cytology • Cervical cells collected in cobas® PCR • Up to 282 tests in less than 12 hours neously provides results on a pool of test was normal cell collection media (Roche Molecular ­“high-risk” genotype­ s, including individual • Expanded U.S. indication to include Systems, Inc.), PreservCyt® solution results on the highest-risk genotypes, screening of women ages 25 – 29 years (Hologic) and SurePath® preservative fluid HPV 16 and HPV 18, giving three ­results in (not approved in the US) just one test. HPV genotypes 16 and 18 Clinically relevant results (BD Diagnostics-TriPath) are known to be responsible for more than • Knowing the patients HPV 16/18 status • Sample volume of 1 mL is sufficient 70 percent of all cervical cancer cases. may impact patient management and ­allow better risk stratification for ­patients at the Absolute risk of ≥ CIN2 by screening strategies assessed in ATHENA at baseline

This test enables physicians to focus on the highest risk ≥CI ≥CI few patients who need more aggressive treatment or careful management, and Report with confidence ­reassures the vast majority of women they • Cellular internal control for assurance Immeiate reerral to olposopy Poole hrP P or 8 are at very low risk, protecting them from of sample integrity disease 4 4 potentially unnecessary interventions. • No cross reactivity with low risk HPV is o highgrade ASCS triage IM aunt sreening ­genotypes ≥ years ≥ years

1 in 10 women ≥30 years of age with negative cytology who tested positive for HPV 16/18 using the cobas HPV test Efficiency had underlying precancerous lesions. Women with negative pap cytology who are HPV 16+ and/or HPV 18+ and • Suited for high volume screening programs­ women with ASC-US who are pooled hrHPV+ share a similar absolute risk of precancer and should be managed • By fully automated sample preparation similarly with immediate referral to colposcopy. workflow process, and unique efficiency feature

124 | 125 Back cobas® Oncology Portfolio Seven to ten days is a long time to wait when every day counts

The cobas ® Oncology Portfolio Your benefit Portfolio menu cobas ® EGFR Mutation Test v2 exemplifies Roche’s commitment to Reliable results cobas® 4800 BRAF V600 Mutation Test • Identifies patients with non-small Personalized Healthcare. The tests • Complete and controlled IVD system • Identifies which metastatic melanoma cell lung cancer who benefit from anti- detect mutations in key biomarkers consisting of the cobas ® DNA ­patients can be considered for BRAF EGFR TKI therapy, e. g. Tarceva ® which helps identify patient­ s who Sample Preparation Kit, the cobas ® ­inhibitor therapy, e. g. Zelboraf® in first-line therapy or TAGRISSO ™ in are most likely to respond to certain cfDNA Sample Preparation Kit, • Detects V600E mutations of the BRAF subsequent-line therapy drug treatments. These clinically cobas ® BRAF, KRAS, EGFR v2 and PIK3CA gene (< 5 % mutant copies in formalin- • Specific detection of 42 mutations validated companion diagnostics help (RUO) Mutation Tests, and the fixed, paraffin-embedded tissue [FFPET]); (insertions and deletions) in exons 18, 19, ­physicians make therapy decisions cobas ® 4800 System, v2.1 or higher also sensitive to V600K and V600D 20 and 21 of the EGFR gene (less than for patient­ s suffering from metastatic • 24 reportable results from a single test kit or equal to 5 % mutant copies in FFPET or melanoma,­ colorectal cancer, and Consistent, objective and • Only requires one 5 µm tissue section with 2 mL of Plasma *) non-small cell lung cancer. Due to the reproducible results > 50 % tumor area for the PCR reaction • 24 reportable results from a single test kit short testing time, physicians can • Automated result interpretation and make decisions in hours instead of days test reporting provide from laboratory cobas ® KRAS Mutation Test cobas ® DNA Sample Preparation Kit when using alternative methods. to laboratory • Offers broad mutation coverage of KRAS • Clearly defined workflow codons 12, 13 and 61 * to identify • Validated with FFPET samples Fast result reporting colorectal cancer patients not likely to • Isolation time: 3 – 4 hours only • Delivering patient results in < 8 hours respond to anti-EGFR monoclonal when testing tissue, and < 4 hours when antibody therapies, e. g., Erbitux ®, Vectibix ® cobas ® cfDNA Sample Preparation Kit testing plasma * • Detects all of the reported mutations in • Cleary defined workflow codons 12, 13, and 61 * of the KRAS gene • Validated with plasma samples * Not available in all tests and markets. (< 5 % mutant copies in FFPET) • Isolation time: ~2 hours • 24 reportable results from a single test kit • Only requires one 5 µm tissue sections with Assay specific analysis packages ≥10 % tumor area for the PCR reaction • Software package containing cycling ­conditions, algorithms and calculations * Not available in all markets. for automated interpretation and report RUO = For research use only. Not for use in of results diagnostic procedures.

126 | 127 Back cobas® HSV 1 and 2 Test Bring more to your sexually transmitted infections­ menu

Due to extremely different outcomes Your benefit Mixed batch testing on cobas® 4800 System ­regarding recurrence, it is essential to Amplified reliability ­determine whether a patient has type 1 or • Robust, dual-target detection amplifies type 2 herpes simplex virus. The cobas two separate regions on each of the HSV 1 and 2 Test, which runs on the cobas HSV-1 and HSV-2 genomes 4800 System, offers exceptional sensitivity • Optimizes sensitivity and specificity MRSA/SA samples C. difficile samples HSV 1 and 2 samples while delivering reliable answers that • Ensures reliable results as new HSV result in optimal patient treatment and strains emerge management decisions. Reduced hands-on time • Just load your primary sample vials Automated sample preparation on the cobas 4800 System and you’re with cobas x 4800 Instrument ready to go

Unmatched flexibility MRSA/SA • Run as few as 6 or as many as 94 samples C . difficile • Process different tests and sample types HSV 1 and 2 simultaneously

Amplification and detection with cobas z 4800 analyzer

Parallel sample processing offers the flexibility to run different tests and sample types, including: • Stool (cobas Cdiff test) • Nasal (cobas MRSA/SA Test) • Anogenital lesions (cobas HSV 1 and 2 Test)

128 | 129 Back cobas® Cdiff Test cobas® MRSA/SA Test The right result the first time Faster than a spreading infection

Clostridum difficile (C. difficile) infection Your benefit Staphylococcus aureus (SA) and methicillin- Your benefit is a major cause of diarrhea in healthcare Exceptional performance resistant Staphylococcus aureus (MRSA) Exceptional performance facilities. By rapidly detecting Cdiff in • Selectively detects a specific Cdiff toxin infections represent a critical threat to • Quickly identify colonized patients and patient stool samples, the cobas® Cdiff Test, gene directly from unformed stool ­samples ­public health. The cobas MRSA/SA Test, take decisive action which is performed on the cobas 4800 using real-time PCR performed on the cobas 4800 System, • Get the sensitivity and specificity that only System, provides accurate information for • Generates robust results automatically, provides innovative solutions for detecting PCR technology can deliver timely treatment and prevention. using patented, state-of-the art ­algorithms both organism variances from a single • Detects the presence of 31 Cdiff toxino- nasal swab specimen, providing timesaving Greater workflow efficiencies types and 20 ribotypes efficiencies and lifesaving answers. • Save time with first-of-its-kind primary sample vial loading Confidence in results • Run MRSA/SA, Cdiff, and HSV 1 and • Lower inhibition rate minimizes invalids 2 samples at the same time, on the same and need for repeat testing resulting in system cost efficiency • Simplify data interpretation with patented, • Reduces possibilities for errors state-of-the-art software algorithms

Unmatched flexibility Automated efficiency • Run as few as 6 or as many as 94 samples • Run 6 to 94 specimens using the fastest, • Process different tests and sample types most advanced real-time PCR amplification simultaneously and detection available today

130 | 131 Back cobas® HCV for use cobas® HCV NEW on the cobas® 6800/8800 System for use on the cobas® 4800 System NEW See what truly matters See what truly matters

The cobas® HCV quantitative nucleic acid cobas® HCV performance summary cobas® HCV quantitative nucleic acid test • Accurate detection and quantification test for use on the cobas® 6800/8800 for use on the cobas® 4800 System, of HCV genotypes 1 through 6 ­Systems delivers robust, clinically relevant Parameter Performance delivers robust, clinically relevant assay • High sensitivity suitable for use with assay performance based on Roche’s Sample type EDTA plasma, serum performance based on the proprietary new HCV therapies ® Minimum amount 650 µL or 350 µL ® proprietary dual-probe assay design. cobas of sample required dual-probe assay design from Roche with • Excellent correlation with the COBAS ® ® HCV provides built-in redundancy with Sample processing 500 µL or 200 µL built-in redundancy for broad genotype AmpliPrep/COBAS TaqMan HCV broad genotype coverage and incorporates volume coverage and improved mismatch tolerance Quantitative Test, v2.0 mismatch tolerance to ensure confidence Analytical sensitivity 15 IU/mL (500 µL) to ensure confidence in viral load (LoD by hit rate of 40 IU/mL (200 µL) in viral load monitoring. cobas® HCV is ≥ 95%) monitoring. cobas® HCV performance designed to deliver high sensitivity to Linear range 500 µL: 15 IU/mL – 1×108 IU/mL 200 µL: 40 IU/mL – 1×108 IU/mL meet the requirements of current and ­future cobas® HCV accurately detects Parameter Performance Specificity 100 % (one-sided 95 % Sample types Serum, plasma chronic hepatitis C therapies. ­confidence interval: 99.5 %) and quantifies all HCV genotypes Genotypes detected HCV genotypes 1– 6 Sample processing 400 µL and 200 µL 1 through 6 volume ® cobas HCV delivers: • Two non-overlapping detection Sensitivity plasma: 9.2 IU/mL (400 µL); • Tight precision at medically-relevant Not commercially available in all countries. probes, when combined with (LoD by PROBIT 15.2 IU/mL (200 µL) at ≥95 % hit rate) serum: 7.6 IU/mL (400 µL); ­decision points two staggered primers, ensure assay 15.3 IU/mL (200 µL) • Accurate detection and quantification performance Linear range 400 µL: 15 – 1×108 IU/mL 8 of HCV genotypes 1 through 6 • Mismatch tolerance to accurately 200 µL: 25 – 1×10 IU/mL Precision 0.06 to 0.10 log10 S.D. across an • High sensitivity suitable for use with quantify with high specificity despite HCV RNA concentration range new HCV therapies changes in the viral genome of 1×103 – 1×107 IU/mL • Excellent correlation with the COBAS® Accuracy plasma: ±0.20 log10 (across the linear (400 and 200 µL) ® ® ® AmpliPrep/COBAS TaqMan HCV cobas HCV delivers: range) serum: ±0.23 log10 (400 µL); ­Quantitative Test, v2.0 • Tight precision at medically-relevant ±0.25 log10 (200 µL) Specificity plasma: 99.5 % ­decision points (95 % confidence limit: 98.7 %) serum: 100% E2 E NS HCV RNA 2 E (95 % confidence limit: 99.5 %) N S3

3’NTR N S 4A

N Not commercially available in all countries. S4 Two B S5B e Reverse Primers NS5A N

Dual JA270-labeled Probes

132 | 133 Back cobas® HCV Genotyping COBAS ® AmpliPrep/ NEW for use on the cobas® 4800 System COBAS ® TaqMan ® HCV qualitative See what truly matters and quantitative Tests, v2.0 Empowering change in HCV

Identification of the infecting genotype is Automated assay providing COBAS ® AmpliPrep/COBAS ® Your benefit required before a patient is prescribed workflow efficiencies TaqMan ® HCV qualitative Test, v2.0 • Reliable results by enhanced mismatch ­antiviral therapy as response to treatment • Time to first result:< 4 hrs and quantitative Test, v2.0 tolerance and coverage of all genotypes correlates to the HCV genotype. • Generates up to 90 reportable results The version 2.0 tests are developed • Economic sample usage Determination of HCV genotype prior in 8 hours with a lower input volume, and innovative • Excellent sensitivity to meet guidelines to treatment initiation has been • Mixed batching capability with HIV-1 dual-probe design to provide improved implemented in inter­national HCV and HCV viral load tests on the sensitivity and precise detection across all Product characteristics treatment guidelines. ­cobas® 4800 System genotypes for the new era of direct • Kit configuration 72 tests/kit • Small sample processing volume: 400 μL acting antiviral agents (DAAs) to distinguish • Sample types EDTA plasma and serum cobas® HCV GT is a highly sensitive true signal from background noise. • Sample input volume 650 µL real-time PCR based test for the qualitative Sensitivity to meet clinical needs • Limit of detection 15 IU/mL identification of HCV genotypes 1 to 6 The COBAS ® AmpliPrep/COBAS ® • Genotype inclusivity genotypes 1 through 6 and genotype 1 subtypes a and b in human Limit of detection (LoD)* TaqMan ® HCV qualitative Test, v2.0 • Diagnostic sensitivity 100 % plasma or serum from individuals with Genotype Serum (IU/mL) Plasma (IU/mL) This test provides a qualitative molecular • Specificity 99.9 % chronic HCV infection, using the cobas® 1a 125 125 diagnostic tool in HCV diagnosis. It is 4800 System. 1b 125 250 indicated for patients who have clinical Workflow 2 50 125 and/or biochemical evidence of liver • Confirm active infection and monitor HCV cobas® HCV GT uses three different target 3 125 125 disease and antibody ­evidence of HCV viral load on the same system regions in the HCV genome (5’-UTR, Core, 4 125 125 infection, and who are suspected to • Flexible batch size with continuous loading NS5B) to achieve excellent genotyping and 5 500 1,000 be actively infected with HCV. Detection • Interleave with other COBAS ® TaqMan ® subtyping accuracy compared to sequencing 6 125 125 of HCV RNA indicates that the virus is Tests (HIV-1, HBV) and the capability to detect both genotypes * Lowest tested concentration with correct genotype replicating and therefore is ­evidence of Not commercially available in all countries. in mixed infections down to a ratio of 1:100. results in at least 95 % of tests active infection. Not commercially available in all countries.

HCV genome organization and targets of cobas® HCV GT

T C S S S4B SA SS T

p S4A

134 | 135 Back cobas® HIV-1 for use on the cobas® 6800/8800 System NEW Stay one step ahead

COBAS ® AmpliPrep/COBAS ® TaqMan ® Product characteristics It takes more than just a single target. cobas® HIV-1 performance summary HCV quantitative Test, v2.0 • Kit configuration 72 tests/kit As the challenges you face evolve, The test can be used to asse­ ss the • Sample types EDTA plasma and serum stay one step ahead with the cobas® Parameter Performance probability of a sustained viral response • Sample input volume 650 µL HIV-1 quantitative test with a dual Sample type EDTA plasma, serum Sample process 500 µL or 200 µL early in a course of antiviral ­therapy • Limit of detection 15 IU/mL target ­approach. volume and to assess viral response to ­antiviral • Linear range 15 IU/mL – 1E108 IU/mL Analytical sensitivity 13.2 cp/mL (500 µL) treatment as measured by changes in • Genotype inclusivity genotypes 1 through 6 Rapidly mutating HIV-1 virus can evade 35.5 cp/mL (200 µL) serum or plasma HCV RNA levels. • Diagnostic sensitivity 100 % quantification with a single target viral load Linear range 500 µL: 20 cp/mL – 1.0E+07 cp/mL 200 µL: 50 cp/mL – 1.0E+07 cp/mL ® • Specificity 100 % assay. cobas HIV-1 quantitative nucleic Specificity 100 % (one-sided 95 % Your benefit acid test for use on the cobas® 6800/8800 ­confidence intervat: 99.5 %) • Precisely distinguish true signals from Workflow Systems targets two unique regions of Genotypes detected HIV-1M (A-D, F-H, CRF01_AE, CRF02_AG), HIV-1O, HIV-1N background noise for more accurate viral • Confirm active infection and monitor HCV the HIV-1 genome, gag and LTR, which are load results viral load on the same system not subject to selective drug pressure. • Reliable results by enhanced mismatch • Flexible batch size with continuous loading This approach­ improves test sensitivity, Drive better decisions for a positive tolerance and coverage of all genotypes • Interleave with other COBAS ® TaqMan ® coverage and security in the event of ­impact on patients’ lives • Perfect tool to aid in response-guided Tests (HIV-1, HBV) mutation in one primer/probe region. • Targeting two regions improves genotype therapy with excellent sensitivity and inclusivity, detects HIV-1 variants and Not commercially available in all countries. specificity delivering accurate results ­potentially avoids under quantification • Economic sample usage required which • Accurate quantification of HIV-1 RNA provides laboratory with enough left over with a dual target assay contributes to sample for other laboratory testing optimal treatment decisions for patient management Roche offers a complete continuum of care to run the key tests for the diagnosis and Not commercially available in all countries. management of HCV

C antiboy test C A quantitative test C A quantitative C A qualitative test Conirmation iral loa monitoring test iral loa o antiboypositive speimens monitoring ss ee ee Ele E ee ecs ee ll

C A quantitative test C A quantitative test iral loa monitoring iral loa monitoring Key steps in the diagnosis and management of HCV

136 | 137 Back cobas® HIV-1 COBAS ® AmpliPrep/ NEW for use on the cobas® 4800 System COBAS ® TaqMan® HIV-1 Test, v2.0 Stay one step ahead A dual-target approach for greater security against the unexpected

It takes more than just a single target. Drive better decisions for a positive An in vitro nucleic acid amplification Your benefit As the challenges you face evolve, ­impact on patients’ lives test for the quantitation of HIV-1 RNA in Dual-targeted approach for greater security stay one step ahead with the cobas® • Targeting two regions improves genotype human plasma. against the unexpected: HIV-1 quantitative test with a dual inclusivity, detects HIV-1 variants and • Provides diagnostic accuracy of test target ­approach. ­potentially avoids under quantification This test enhances the reliability of test results even if mutations occur in one • Accurate quantification of HIV-1 RNA results and provides greater confidence of the two regions Rapidly mutating HIV-1 virus can evade with a dual target assay contributes to in assessing viral loads. It also increases • Compensates for the possibility quantification with a single target viral load optimal treatment decisions for patient the probability of detection and expands of mismatch occurring with a primer/ assay. cobas® HIV-1 quantitative nucleic management coverage by targeting two highly conserved probe region acid test for use on the cobas® 4800 regions of the HIV-1 genome to compensate • Ensures enhanced reliability of test ­System targets two unique regions of the cobas® HIV-1 performance summary for the possibility of mutations or mis- results and more confidence in assessing HIV-1 genome, gag and LTR, which are not matches. The test provides diagnostic viral loads subject to selective drug pressure. This Parameter Performance accuracy in test results even if mutations • Offers increased sensitivity and linear ­approach improves test sensitivity, coverage Sample types EDTA plasma occur in one of the two regions. range for accurate measurement of Sample process 400 µL or 200 µL and security in the event of mutation volume viral suppression ® in one primer/probe region. Analytical sensitivity 14.2 cp/mL (400 µL) This test uses the COBAS AmpliPrep 43.9 cp/mL (200 µL) Instrument to automate specimen processing Linear range 400 µL: 20 cp/mL – 1.0E+07 cp/mL and the COBAS ® TaqMan ® Analyzer or 200 µL: 60 cp/mL – 1.0E+07 cp/mL ® ® Specificity 100 % (one-sided 95 % COBAS TaqMan 48 Analyzer to automate ­confidence interval: 99.5 %) amplification and detection. Genotypes detected HIV-1M (A-D, F-H, CRF01_AE, CRF02_AG), HIV-1O, HIV-1N

Not commercially available in all countries.

138 | 139 Back COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0 The trusted choice for Hepatitis B viral load testing

Product characteristics • Offers increased sensitivity and linear Improve patient management and treatment Your benefit • Offers primers and probes that are range for accurate measurement of viral success. • Confidence in assay design with opti- used to amplify the gag and LTR regions suppression mized primer-probe selection targeting • Provides LTR primers that have • Has a lower limit of detection (LOD) Fully automated viral load quantitative highly conserved pre-core and core broad genotype inclusivity and are and 100 % specificity at 20 copies/mL than hepatitis B test used in the management of regions. The amplified region of the well conserved phylogenetically previously available HIV-1 tests patients with chronic hepatitis B infection genome will not be affected by mutations • Quantifies the clinically significant • Is fully traceable to WHO international undergoing antiviral therapy. that arise due to drug resistance HIV-1 groups and subtypes with full standards subtype coverage and quantification The test provides clinically relevant assay • Confidence in detection with multiple Not commercially available in all countries. of HIV-1 groups O and M performance, and high sensitivity to layers of contamination control including • Quantitates HIV-1 RNA from deliver optimal results throughout critical built-in AmpErase , optimized 20 – 10,000,000 copies/mL medical decision points and across all pipetting and workflow settings and genotypes, all combined with fully automated verified low rates of cross contamination sample extraction and real-time PCR amplification and detection for a highly • Confidence in measuring HBV DNA with efficient laboratory workflow. high precision at medical decisions points translates into confidence in each result regardless of HBV DNA level

• Confidence through clinical validation – Roche HBV viral load tests have been the most widely used tests in pharmaceutical trials worldwide providing a link between clinical practice and clinical trials

140 | 141 Back COBAS® AmpliPrep/ COBAS® TaqMan® CMV Test Setting the standard in assessing virological response in CMV infection

Roche HBV Tests in clinical trials for approved HBV drugs on the market Improve disease management and patient Your benefit care with a Roche real-time, fully automated With the COBAS® AmpliPrep/COBAS® Generic Name Trade Name Date FDA Approved PCR test. TaqMan® CMV Test, you can be reassured ® Interferon alfa-2b INTRON A 1991 that you are requesting: ® Lamivudine EPIVIR-HBV 1998 Cytomegalovirus (CMV) is a leading cause Adefovir dipivoxil HEPSERA™ 2002 of morbidity and mortality in transplant • A test that fulfils international guideline Entecavir BARACLUDE™ 2005 recipients. Severe CMV infection in recommendations – demonstrating ® Peginterferon alfa-2a PEGASYS 2005 high risk patients may develop soon after co-linearity to the WHO international Telbivudine TYZEKA™ 2006 transplantation and without effective standard and reports results in IU/mL, Tenofovir VIREAD (HIV) 2008 treatment, may lead to CMV syndrome, as recommended by the international tissue invasive disease, and potential consensus guidelines for CMV manage- Not commercially available in all countries. rejection or loss of the graft. Roche’s CMV ment in solid organ transplant patients 1,8 Test reliably monitors Cytomegalovirus (CMV) infection in patients receiving anti- • A test that is clinically validated – Used in viral therapy. key clinical studies, demonstrating clinical utility of CMV viral load monitoring 3,9

• A test that provides reproducible and reliable results – proven to provide reliable, comparable and reproducible viral load results across different institutions, over several orders of magnitude.6 The first standadized CMV viral load test with CE and FDA approval 8

Not commercially available in all countries.

142 | 143 Back COBAS® TaqMan® MTB Test Rapid MTB detection

CMV viral load test standardization enables improvement in CMV infection Tuberculosis is the world’s most common Your benefit management4,5 infectious disease, with two million deaths • Fast results in only 3.5 hours including annually. Due to the risk and severity of sample preparation Comparability of the Roche CMV Test results Comparability of LTD results across five the disease, rapid diagnosis of the M. tuber­ • Reliability of test results across five laboratory testing sites laboratory testing sites culosis-complex is extremely important. – high sensitivity and specificity ­Routine cultures are time-consuming and – clear differentiation of the pathogen can take up to eight weeks. Microscopic from atypical mycobacteria (MOTT) examination of acid-fast smears is insensi- – contamination protection through tive and nonspecific. The COBAS TaqMan ­AmpErase System MTB test has further improved the rapid • Efficient workflow, no manual steps ­diagnosis of tuberculosis by ­allowing ­required after sample preparation direct detection of mycobacteria in clinical • Proven and safe sample preparation with specimens. the A­ MPLICOR respiratory specimen ­preparation kit

1 Asberg, A., Caliendo, A. M., Chou, S., Kotton, C. N., Kumar, D. et al. (2013). Updated international consensus guidelines on the management of cytomegalovirus in solid-organ transplantation. Transplantation 96, 333-360. 3 Åsberg, A., Boisvert, D., Caliendo, A.M., Do, T.D., Rollag, H,, Duncan, J., Humar, A., Razonable RR, Yao, J.D. (2013). Virologic suppression measured by a cytomegalovirus (CMV) DNA test calibrated to the world health organization international standard is predictive of CMV disease resolution in transplant recipients. Clin Infect Dis. ;56:1546–1553. 4 Caliendo, A. M., Fenton, J. M., Fox, J. D., Miller, G. G., Pang, X. L. et al. (2009). Interlaboratory comparison of cyto- megalovirus viral load assays. Am J Transplant 9, 258-268. 5 Abdul-Ali, D., Caliendo, A. M., Ingersoll, J., Schaper, C., Shahbazian, M. D. et al. (2009). A commutable cytomegalovirus calibrator is required to improve the agreement of viral load values between laboratories. Clin Chem 55, 1701-1710. 8 COBAS ® AmpliPrep/COBAS® TaqMan® CMV Test package insert data 9 Åsberg, A., Hartmann, A., Humar, A., Jardine, A. G., Mouas, H., Noronha, I.L., Pescovitz, M. D., Rollag, H., Sgarabotto, D., Tuncer, M., and on behalf of the VICTOR Study Group (2007), Oral Valganciclovir Is Noninferior to Intravenous Ganciclovir for the Treatment of Cytomegalovirus Disease in Solid Organ Transplant Recipients. Am J of Transplant, 7:2106–2113 COBAS TaqMan 48 Analyzer and MTB kits

144 | 145 Back LightCycler® MRSA Advanced Test Enabling improved infection control

Product characteristics The incidence of hospital-associated Your benefit • Detects pathogens of the Mycobacterium ­methicillin-resistant Staphylococcus aureus • Fast results: Results available within tuberculosis complex (M. tuberculosis, (MRSA) is on the rise around the globe. 100 min. M. bovis, M. africanum, M. microti) Studies in Europe and the United States • Simple: Sample preparation procedure • Test is performed on the IVD CE-marked suggest that 28 – 34 % of patients infected ­involves no pipetting steps COBAS TaqMan 48 Analyzer that allows with MRSA will even die from their infec- • Flexible: Validated for use with variable batch sizes – between 1 and tion. These findings have serious implica- 3 different swabs and provided in 48 tests per run tions for patients, physicians, and hospitals. a convenient, ready-to-use format • Internal controls included in the same The increased rates of MRSA also have • Reliable results: The only rapid MRSA ­reaction batch significant economic implications. test containing the Roche AmpErase® • Specificity: 99 % ­enzyme, able to prevent carry-over • Sensitivity: 0.46 CFU/PCR, corresponding The LightCycler MRSA Advanced test ­amplicon contamination that lead to to a calculated concentration of ­offers a simple, flexible and reliable way false positive results 18 CFU/mL sputum to incorporate MRSA surveillance into your hospital’s infection control program.

Ensure fast and simple operation

146 | 147 Back cobas® 6800/8800 Systems Own the future www.cobas68008800.com

The cobas 6800/8800 Systems are new Your benefit Product characteristics molecular testing platforms, available in Unparalleled Performance Ready-to-use reagents do not Uni- and bi-directional LIS medium and high throughput models, Rapidly complete daily testing requirements require thawing, mixing or pouring interface simplifies order and designed for donor screening, viral load with trusted and reproducible results. result handling monitoring, women’s health, and Automated onboard storage and micro​-biology testing. Absolute Automation refrigeration system enable ready System connectivity: up to five Allows you to focus on more complex testing access and maintain inventory of analytic systems and four cobas The cobas 6800 System and the higher demands while increasing productivity within consumables and reagents p 680 instruments managed throughput cobas 8800 System are the lab. by a single instrument gateway designed to be readily integrated into Radio-frequency identification laboratory workflow from pre-analytic Unmatched Flexibility (RFID) and barcodes ensure Gain valuable “work-away” time to post-analytic solutions. Run the tests you want when you want full traceability from sample in by consolidating your LDTs with For more information visit www.cobas68008800.com with minimal user interactions. to results out routine IVD tests with the cobas omni Utility Channel Automated pre-analytic sample handling Consolidated menu Offers a broad and expanding menu to meet your needs today and in the future.

Blood Screening Viral Load Diagnostic Testing * Dual-target for HIV-1 and dual-probe for HCV Today Monitoring Tomorrow ** ** Currentliy in development cobas p 312 cobas p 512 cobas p 612 cobas ® connection † Dual-target pre-analytical system pre-analytical system pre-analytical system modules MPX* HIV-1† CT/NG †† Dual-probe Virus + + WNV HBV HPV Bacteria Sorting Decapping Tube type Sample Aliquoting with barcode DPX HCV†† MTB/MAI ID volume labelling The cobas® 6800/8800 Systems are not available detection HEV in all markets. Fully automated, CMV HIV Qual Sample Recapping multidisciplinary up to up to quality 8 connectivity 4 te te s s Archiving Recursive t t s s workflows Centrifu- Bulk gation loading

450 sample/hour 1,100 samples/hour 1,100 samples/hour

* may vary based on workflow demands

148 | 149 Back cobas® 4800 System Works the way you do

The cobas® 4800 System offers state-of-the- Your benefit Test menu art, fully automated sample preparation, Reliable results Virology Microbiology & Genomics & Oncology Diagnostic testing ­real-time PCR amplification/detection and • Proprietary kinetic algorithm software Women’s Health tomorrow ** easy-to-use software for multiple sample provides clear and precise answers HIV-1 † HPV BRAF TV/MG types (the detection of C. trachomatis (CT), ­reducing the need for retesting or HBV CT/NG KRAS Factor II/V N. gonorrhoeae (NG), HPV (human interpretation­ †† ­papillomavirus) virology and an expanding HCV HSV-1/2 EGFR V2 KRAS Plasma menu of assays. Efficiency HCV GT C.diff • By fully automated sample preparation MRSA/SA It consists of the cobas x 480 Instrument and PCR set-up (for HPV, Virology, for the nucleic acid extraction sample and CT/NG) ** Currently in development Virus † Dual-target Bacteria ­preparation and PCR pipetting and the • By bidirectional connectivity with your †† Dual-probe Variant ­cobas z 480 real-time PCR analyzer. LIS for automated results reporting Product characteristics The cobas z 480 analyzer is also available Flexibility • Processes up to 376 samples in 10 h • Easy to use software as single system and can be used for • Possibility to use multiple primary vial types • Bidirectional connectivity to LIS • Automated result interpretation ­parameters in the oncology field like BRAF, • User defined workflow software for free for HPV and CT/NG KRAS and EGFR. programmable PCR applications cobas ® Pre-analytic Systems Load-and-go reagents • Save time and labor Primary & secondary automated pre-analytical sample handling • Low daily maintenance requirements Decapping Recapping

Aliquoting Reagent addition & heating cobas p 480 Instrument for use with cobas® 4800 System Four customizable workflows

cobas x 480 Instrument cobas z 480 analyzer

150 | 151 Back COBAS ® AmpliPrep/ COBAS ® TaqMan ® System Easy Begins Here

The COBAS ® AmpliPrep/COBAS ® Your benefit Product characteristics • Up to four independent thermocyclers, TaqMan ® System, a real-time PCR system, Safety and reliability COBAS ® AmpliPrep Instrument each with 24 positions unites primary tube handling with fully • Closed tubes for samples and purified • Ready-to-use reagents in barcoded • Run time: 2.5 – 3.5 hours automated sample preparation, amplification nucleic acids minimize contamination cassettes • Run up to 192 samples in 24 hours and detection of RNA or DNA. The • Sample tracking with barcoded tubes • Complete 72 samples; up to 144 easy-to-operate system provides high prevents sample mix-ups purifications per day or approximately Test menu throughput­ processing for a menu 15 – 24 samples/hr With manual sample preparation of important molecular tests including HIV, Efficiency • Detection of liquid level and clots • HCV quantitative HCV, HBV, and CMV. The system • Handles up to four tests simultaneously; • Controllable via data station with • HBV quantitative improves workflow efficiencies with the continuous reloading during the run AmpliLink ® software, for laboratory • HIV-1 quantitative COBAS® AmpliPrep Instrument for • Ready to use reagents – no aliquotting or integration with LIS • Chlamydia trachomatis qualitative automated extraction of DNA and RNA mixing required • Barcoded data input • Mycobacterium tuberculosis qualitative using magnetic bead technology • Overnight runs and the COBAS® TaqMan® or COBAS® • Additional generic sample preparation for COBAS ® TaqMan ® Analyzers With automated sample preparation TaqMan® 48 Anayzers for automated other PCR systems increases the versatility • A docking station can combine • HCV qualitative and quantitative real-time amplification and detection of of the instrument COBAS ® AmpliPrep Instrument and • HBV quantitative DNA or RNA for up to 96 samples COBAS®TaqMan ® Analyzer into • CMV quantitative and four assays at the same time. Reliability for routine PCR a single, fully automated system that • HIV-1 quantitative • Reliable results within two to three hours can perform sample preparation, • HLA–B * 5701 • Sensitive, highly linear tests can PCR set-up and amplification/detection • HIV-1 qualitative * handle both low titer and high titer samples in the same run * Not commercially available in all countries. • Greater safety due to AmpErase enzyme contamination prevention and internal controls for detecting possible PCR inhibitors

COBAS® TaqMan® 48 Analyzer COBAS ® AmpliPrep/COBAS ® TaqMan ® System

152 | 153 Back cobas® Liat System We put a lab in a tube, because they put their www.cobasliat.com trust in you

The cobas Liat System incorporates Roche Your benefit Product characteristics real-time PCR technology in a compact, fully Accuracy • No complex set up automated bench top analyzer. • Roche PCR technology • Runs single assays on single • Definitive, reproducible, objective patient samples The self-contained cobas Liat Analyzer • All assay components fully enclosed — no and its uniquely segmented assay tubes Speed direct operator contact with reagents or allow the efficient use of Roche PCR in the • Analysis in less than 20 minutes, other solutions time-sensitive analysis of individual patient to expedite diagnosis and treatment • Easy, 3-step process samples — with definitive results generated • Single-sample testing, to enable • Definitive, objective results in less than 20 minutes. immediate response • Over 20 controls including comprehensive real-time monitoring Closed-system design and multiple process Ease-of-use • Touchscreen options allow viewing of controls make it ideal for adoption by satel- • No technical training required real-time PCR curve lite labs, physician offices and pharmacies. • Touchscreen-guided operation, • Printer connectivity for report outputs minimizes potential for human error Analyzer dimensions and weight Safety 24.1 × 11.4 cm × 19.0 cm, 3.76 kg • Multiple process controls • Completely closed system cobas® Liat Assay Menu • Minimal risk of contamination cobas Influenza A/B Space-Efficiency cobas Influenza A/B + RSV * • Small bench top footprint cobas Strep A Additional assays in development

* Not available in all markets including the US.

Sample Scan Start

154 | 155 Back cobas s 201 System The first multi-dye nucleic acid testing (NAT) screening system

The cobas s 201 system is a complete Your benefit Product characteristics cobas® TaqScreen DPX Test NAT solution able to meet both current and • Full automation including optional ­pooling Scalable, modular system • Simultaneous quantitative detection ­future needs of blood screening labs. and archiving with minimal hands-on time • Flexible, mix-and-match scalability helps of parvovirus B19V DNA and qualitative for the entire testing process NAT labs work more efficiently ­detection of HAV This system provides the efficiency • Confidence in the test results through full • Supports simultaneous multiple assay • B19V target values are traceable to the and ­reliability of real-time polymerase process control processing WHO B19V International standard chain ­reaction (RT-PCR) technology, • Comprehensive assay menu with ready- • Accommodates integrated backup to modular ­automation, convenient ready- to-use reagents maximize lab productivity cobas ® TaqScreen WNV Test to-use ­reagents and a robust­ menu • Built-in viral target resolution through • Qualitative in vitro test for the direct selection. New assays utilize multi- multi-dye technology makes confirmation Pooling and data management server ­detection of West Nile virus (WNV) RNA channel capabilities to provide real-time testing obsolete • Single server, accommodating multiple in human plasma discrimination of major ­viruses. instrument configurations and providing • Screening test for donations of whole the added security of built-in redundancy blood and blood components The system is backed by world-class • Capable of detecting other members ­service and strong local support in over Test menu of flavivirus that have been implicated in 140 countries. • Reagents are ready-to-use with built-in ­fusion transmitted infectious disease contamination control • No freezers required, reagents are stored at 2 – 8° C • Stabilized reagents obsoletes calibrations

Pooling and data management server cobas ® TaqScreen MPX Test, v2.0 • Cover 5 critical viral targets (HIV-1 Group M, HIV-1 group O, HIV-2, HCV and HBV) in one easy-to-use assay • Immediate virus discrimination in a single assay, no need for virus discriminatory testing

Hamilton MICROLAB STAR COBAS® AmpliPrep Instrument and Pipettor instrument for automated pooling COBAS® TaqMan® Analyzer combined with a docking station

156 | 157 Back FLOW Solution NEW Unleash your potential ldtsolution.roche.com/FLOW

The Roche FLOW Solution delivers ultimate FLOW Flex flexibility based on your instrument • Offers medium-throughput capabilities configuration. It offers complete workflow • Uses one pipetting instrument for standardization and data automation for ­improved cost effectiveness your entire lab developed testing process. By moving your sample information from FLOW Classic your lab information system through all • Offers high-throughput capabilities instruments with complete data safety and • Uses two pipetting instruments for higher sample tracking, the FLOW Solution throughput capabilities enables you to generate accurate results Your benefit with less effort than ever before. Stay Flexible Increase Productivity The FLOW Solution helps you stay ahead The FLOW Solution delivers automation of a quickly shifting market: and higher throughput: • React quickly and effectively to changing • Process more samples with less effort environments • Minimize hands-on time • Make use of self-developed assays or • Report more than 2,000 results in less ­solutions supplied by Roche than 8 hours • Adapt a highly modular instrument setup Nucleic Acid qPCR Setup Amplification Primary Sample to your needs The FLOW Solution is for General Lab Use. Purification Detection

Ensure Result Safety The FLOW Solution delivers more accurate results: • Utilize a completely paperless data ­transfer process • Enables software connectivity between Roche Primary MagNA Pure 96 Roche PCR Set-up Roche qPCR the lab LIS and FLOW Solution Sample Handling Instrument • Use the Roche process control to monitor the workflow

158 | 159 Back LightCycler® Systems Excellence in real-time PCR www.lightcycler.com

Whether your interest is in gene expression Your benefit Available reagents profiling or in detecting genetic variations, High precision • Generic kits for qPCR and RT-qPCR there is a member of the LightCycler® • Reproducible results independent of • Parameter-specific kits Research Use Only ­System family offering the analytical perfor- the sample position including assays from TIB MOLBIOL for mance and throughput you need for your pathogen detection research. High flexibility • Parameter-specific kits IVD • Suitable for all common assay formats • Ready to use custom assays and panels Supported by a broad range of software and dyes for all available LightCycler® Systems tools, real-time PCR based analysis can be (e.g., Universal ProbeLibrary and RealTime performed in 32 capillaries or plastic tubes, High sensitivity ready) interchangeable 96-/384-well plates, or • Even single copies can be detected • Optimized line of LightCycler® ­consumables ­using the unique 1536-well formats. High operator convenience Product characteristics For additional information, visit • Data analysis according to your needs LightCycler® 2.0 System LightCycler® 96 System LightCycler® 480 System (96/480) lifescience.roche.com or www.lightcycler.com Throughput 32 reactions 96 reactions 96 or 384 reactions Versatility Hardware 6 detection channels 4 excitation and 5 excitation and • Absolute or relative quantification, 4 detection filters 6 detection filters ­melting curve analysis or genotyping – Disposable Capillaries 96 multiwell plates 96 or 384 multiwell plates or tube strips or tube strips the software offers all options System features • Excellent temperature homogeneity in all wells/vessels • No need for passive reference dyes • 40 cycles are possible in 40 minutes • Freely programmable protocols, data import and export, creation of macros, and templates. Assay formats SYBR Green I, hydrolysis SYBR Green I, hydrolysis SYBR Green I, hydrolysis and and hybridization probes probes hybridization probes Applications • Absolute Quantification • Absolute Quantification • Absolute Quantification • Relative Quantification • Relative Quantification • Relative Quantification • Tm Calling • Tm Calling • Tm Calling • Melt-Curve Genotyping • Endpoint Genotyping • Melt-Curve Genotyping • Endpoint Genotyping • Qualitative Detection • Endpoint Genotyping • Qualitative Detection • High-Resolution Melting • Qualitative Detection (HRM) • High-Resolution Melting (HRM) • Multiple Plate Analysis

LightCycler ® 2.0 LightCycler ® 96 System LightCycler ® 480 System LightCycler® 2.0 Instrument is available as IVD in many countries. System (IVD) Information about the high-throughput LightCycler® 1536 System is available on request. For life science research only. Not for use in diagnostic procedures unless otherwise noted.

160 | 161 Back LightCycler® 2.0 Instrument For medical research

The LC 2.0 System is a proven standard of Your benefit Product characteristics excellence with its high precision thermo­ • Safety and ease of use in the IVD mode, • Compact benchtop model cycling, state-of-the-art quantification including test-specific reagent kits, and • Fast run of 35 cycles in 40 minutes ­software, and numerous high-quality kits PCR macros that can automate instrument • Reaction batch of 1– 32 samples 20 μL for a wide range of applications in in vitro programming, test analysis and result or 100 μL capillaries diagnostics and in medical research. ­reporting • 6 detection channels for 530, 560, 610, • The research mode offers flexible 640, 670, and 710 nm Data display for a qualitative detection analysis It generates fast and reliable results programming, editing and user evaluation • Versatile detection formats: SYBR Green, through its innovative features, including - Versatility in application options e.g., hybridization probes, hydrolysis probes, the single air-driven chamber, which en- qualitative and quantitative detection, SimpleProbe probes, Scorpion primers, sures ultra-precise temperature regulation mutation detection by melting curve and other FRET-based detection formats for the highest accuracy and reproducibility. analysis and SNP genotyping - Broad choice of detection formats Test kits, validated for IVD • CMV quantification • EBV quantification • HSV 1/2 detection and differentiation • VZV detection • MRSA advanced detection Genotyping analysis • SeptiFast identification of bacteria * More details on following page. and fungi • SeptiFast mec A resistance screening • Factor V mutation detection • Factor II mutation detection

For medical research • HAV quantification • Parvo B19 quantification

LightCycler ® 2.0 • VRE resistance screening System (IVD) • Translocation (9;22) quantification

162 | 163 Back MagNA Pure Systems Breakthroughs have a beginning starthere.roche.com

Your genomic workflow begins with Your benefit nucleic acid purification. Roche Molecular • Extract a wide range of starting materials Diagnostics has revolutionized automated • Simplified sample preparation for sample preparation with nearly 2 decades ­dramatic reduction of handling errors of expertise. Enhancing your laboratory • Preloaded protocols for a broad range workflow, the MagNA Pure Systems offer of sample types automated, flexible, and consistent • Pre-filled and barcoded reagent kits solutions.­ • Intuitive software and guidance Discover the right solution for you Start confidently and increase your workflow efficiency with Roche manual and automated solutions. Use the table below to guide your next nucleic acid extraction.

Product characteristics

MagNA Pure MagNA Pure LC 2.0 MagNA Pure 96 Compact System System System # of Samples 1 – 8 samples per run 1 – 32 samples per run 1 – 96 samples per run Run Time ~30 min. ~1 hour ~1 hour Starting Samples Whole Blood, Plasma, Serum, Cell Culture, Tissue, Body Fluids, Fresh Frozen and FFPE Tissue, Swab, Stool, Sputum Nucleic Acid Targets Genomic and Bacterial DNA, Viral DNA/RNA, Plasmid DNA and Total RNA

MagNA Pure Compact and MagNA Pure LC 2.0 Systems are for general laboratory use. MagNA Pure MagNA Pure LC 2.0 System MagNA Pure 96 System MagNA Pure 96 Systems are for in vitro diagnostic use. Compact System

164 | 165 Back cobas p 480 instrument Automating your primary vial preprocessing steps

The cobas p 480 instrument improves Product characteristics Reduces hands on time and repetitive motions with four unique workflows laboratory efficiency by allowing valuable Improves sample reproducibility and technician time to be used more productively, process reliability eliminating repetitive, manual sample • Sample chain of custody is assured handling, improving workflow and reducing with primary and secondary vial barcode risk of contamination, human error and matching workplace injury. • All vials are spun prior to opening to

remove potentially contaminating droplets 1 2 Your benefit from sample caps Improving laboratory efficiency • Precision pipetting using CO-RE tip, Total Decapping Recapping Removes caps from primary tubes for testing Recaps sample vials with new caps to avoid ® • Accepts PreservCyt , SurePath™ liquid Aspirate and Dispense Monitoring and on the cobas® 4800 System. contamination. based cytology vials as well as Anti-Droplet Control technologies reduce cobas® PCR Media and cobas® PCR Cell opportunities for contamination and Collection Media primary vials ensure sample integrity • Processes four vials simultaneously • No LIS or data connection required • Intuitive interface requires minimal training • Printable reports capture all sample • High throughput automation allows a ID’s, sample error and reagent lot and

single cobas p 480 instrument to support expiration information 3 4 up to two cobas® 4800 Systems, delivering Aliquoting Reagent addition and heating * Aliquots configurable volumes from PreservCyt®, Addition of cobas® Sample Prep Buffer and Up to 376 cobas® SurePath™ and cobas® PCR Cell Collection incubation of specimens collected in SurePath™ 376 4800 System results Media primary vials into barcode matched medium to reverse cross-linking and free in 8.7 hours secondary tubes Compatible with SurePath™ nucleic acids for testing1. vials with plastic inserts.

Up to 470 cobas® 1 Kiernan, J.A. Preservation and retrieval of antigens * cobas® Sample Prep Buffer and use of SurePathTM 470 4800 System results for immunohistochemistry – methods and Medium with the cobas® HPV Test are not approved by in 8.5 shift * mechanisms Part 2. Retrieving masked antigens the FDA for use in the United States. Department of Anatomy and Cell Biology. The Cutting Edge, 5-11. Decapping workflow using 1 cobas p 480 instrument and 2 cobas® 4800 Systems. * Final run completes overnight.

166 | 167 Back cobas p 630 instrument The pre-analytics solution that makes life easier

The cobas p 630 instrument offers in Your benefit Product characteristics ­combination with the COBAS® Efficiency • Uncapping and recapping of the AmpliPrep/COBAS® TaqMan® System • Automated handling of primary and sample tube a fully automated pre-analytical ­secondary tubes • Pipetting Roche controls from control solution for primary tube handling. tubes to sample tubes The system automatically pipettes Flexiblility • Pipetting samples from primary and primary and secondary tubes and • Compatible with a variety of sample tubes ­secondary tubes to sample tubes controls into sample input tubes • Modular design • Multiple tests can be ordered on a single for the COBAS ® ­AmpliPrep Instrument. primary tube Full traceability • Only one LIS interface required The cobas p 630 instrument can • Barcode tracking from patient tube to ­result be ­combined with up to three Unit dimensions COBAS ® AmpliPrep Instruments Process surveillance • 112 cm wide, 101 cm deep, 90 cm high and AmpliLink software to ­ • Monitors liquid handling ensure full traceability of workflow. Sample processing throughput • 320 samples on board • 154 tubes per hour for 650 μL samples • 149 tubes per hour for 1.0 mL samples • 157 tubes per hour for 500 uL samples

cobas p 630 Instrument

168 | 169 Back cobas p 680 instrument Supports the creation of sample pools for use with the cobas® 6800/8800 Systems

The cobas p 680 instrument automates Your benefit Product characteristics the creation of pools in secondary tubes Improved workflow efficiencies Flexible Pool Creation and pipetting of samples into aliquot plates • Automated loading of racks onto Creation of pools with fewer samples than for archiving. From a deck capacity of 500 instrument, once rack tray is deposited the configured pool size (e.g., creation of tubes, primary pools of 1, 6, 24, 96 and 480 • Error lane allows user to easily identify a pool of six with five samples); additional may be created. The instrument utilizes tubes with pipetting errors aliquots will be taken from samples to Roche standard 5-position racks and rack complete the pool. Aliquot plates may be trays to help streamline workflow with Confidence in full traceability created offline for sample archiving. Roche pre-analytics and analytic systems. • Full integration in the cobas 6800/8800 The cobas p 680 instrument combines Systems software ensures full traceability TADM proprietary pipette tip technology and liquid of sample pool creation to final result Total aspiration and dispense monitoring level monitoring to ensure reliable sample • Secondary tubes are barcoded for (TADM) of the pressure within the pipette transfer during pooling. Connect up to improved workflow efficiency and full tip during the pipetting process ensures four cobas p 680 instruments to the cobas® traceability accurate sample transfer. 6800/8800 Systems to meet your lab’s needs. Liquid level detection Capacitive liquid level detection monitors the level of sample in a tube or plate to prevent overflow and carryover contamination during pipetting.

CO-RE tip technology Compressed O-ring expansion (CO-RE) tip technology locks pipette tips in place with an expanding O-ring. The tip is released when the O-ring gently decompresses, preventing the creation aerosols to minimize contamination. Disposable filter tips are utilized to prevent cross-contamination. cobas p 680 instrument

170 | 171 Back

Roche Blood Safety Solutions

Blood screening laboratories are managing The cobas systems are designed to Safe blood supply critical workflow processes and provide ­efficiently fulfill the demanding safety and ­uninterrupted service to ensure timely release reliability blood bank standard. All of safe blood products. supported by a first-class team of skilled Nucleic Acid Testing professionals in your area who are Roche understands that challenge and ready to respond when needed most. Serology is dedicated to be a trusted partner now Blood screening laboratories and in the future. Roche Blood Safety Solutions offers a Pre-analytics ­comprehensive portfolio through Personalized Lab Automation which IT solutions integrates nucleic acid testing, serology testing, pre-analytics and IT solutions. Roche is the first company to offer a Reliable results ­connectivity of serology and nucleic acid testing, setting new standards in your Full automation daily routine. Roche Blood Safety Solutions Efficient processes

172 | 173 Back Roche Blood Safety solution NEW Striving for continual improvement to meet blood banks’ evolving needs

Your benefit Test menu

Reliability Safety Serology:

• Innovative technologies tailor-made to • State-of-the-art assay sensitivity and anti-HCV II anti areen M

meet individual needs genotype coverage allow reliable antigM L areen M

• Systems which have the highest ­detection at the earliest detectable stage HBsAg II sg u hagas areen

reliability on the market while preventing of infection in all parts of the world anti-HBs II areen ombi g cross-contamination and offering • Highly standardized processes which anti-HBc obas M M g ubea full ­sample traceability reduce manual handling and risk of anti-HBc IgM Basi Chart obas M gM ubea gM error­ HBeAg obas M g a oo g Efficiency anti-HBe • High assay specificity and the innovative A fully integrated g oo gM obas multi-dye technology reduce the need g oo g a obas

for retesting system for yphiis • Short turnaround times, ­automation standardizing blood Bloosreening assays Aitional serology assays and uninterrupted workflow generate Prout uner evelopment time savings bank workflow Solution components

Technologies that support timely and reliable release of safe blood supply

Serology Nucleic Acid Testing Pre-analytics & IT

cobas e 411 cobas 6000 cobas 6800/8800 cobas cobas cobas CCM p 312 p 512 p 612

cobas IT solutions cobas infinity blood safety cobas IT middleware cobas 8000 cobas s 201

Please contact your local Roche representative for detailed information.

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Point-of-care testing

The goal of Point of Care from Roche is to While the responsibility for providing the Point of Care help both healthcare professionals and service is in the hands of professionals, we ­patients achieve improved clinical and also provide IT tools to be able to control CoaguChek health-economic outcomes, by delivering all aspects of testing to ensure quality robust, connected, easy to use point-of- patient­ care: care solutions outside the central lab, pro- • Provide accurate and timely analyses and Anticoagulation viding immediate results and thus allowing match them to the right ­patient treatment decisions to be made more • Ensure that operators are competent in Glucose quickly – inside or outside the hospital. the use of the system • Provide reports that are useful to the Accu-Chek Point of Care delivers those solutions meet- ­clinician treating the patient ing the clinical need for quick and accurate • Document testing and QC for audit POC IT test results delivered where needed, when purposes­ needed; on the device, in the electronic cobas healthcare record on a patient/ward monitor, For coagulation patient self-monitoring to the clinician on the move and directly to we also provide solutions for remote Cardiovascular the patient. ­support and monitoring.

Diabetes For more information please visit www.cobas.com Dyslipidemia and www.CoaguChek.com Critical care

176 | 177 Back Overview of point-of-care diagnostic tests www.cobas.com XS Pro XS Pro

® ® ® ® Plus Plus ® ® ® ® ® ® Plus and Plus and sprint Plus and Plus and sprint ® ® ® ®

cobas b 101 Reflotron Combur Combur (visual strips) TROP T sensitive (visual strip) cobas h 232 Accu-Chek cobas b 101 Reflotron Combur Combur (visual strips) TROP T sensitive (visual strip) cobas h 232 Accu-Chek CoaguChek Accutrend Inform II CoaguChek Reflotron cobas b 123* cobas b 221* Urisys 1100 CoaguChek Accutrend Inform II CoaguChek Reflotron cobas b 123* cobas b 221* Urisys 1100 Anemia Myoglobin • Bilirubin •••• D-dimer • Bilirubin neonatal •• HDL cholesterol (or HDL-C) •• Hemoglobin total • •••• LDL cholesterol (or LDL-C) •• Hematocrit •• NT-proBNP • Oxygen saturation (sO2) •• Coagulation Blood gas D-dimer • pH •• PT (INR/% Quick/sec.) •• pCO2 •• aPTT • pO2 •• Metabolic Electrolytes Ca2+ •• Ca2+ •• Cl- •• Cl- •• Glucose •••••• K+ •• HbA1c • Na+ •• HDL cholesterol (or HDL-C) •• CO-oximetry Ketone • • tHb-COOX •• LDL cholesterol (or LDL-C) • O2Hb •• Lactate •••• HHb •• Potassium ••• COHb •• Sodium •• MetHb •• Total cholesterol (or CHOL) ••• sO2 COOX •• Triglycerides (or TG) ••• Bilirubin neonatal •• Hepatology Barmetric pressure (Baro) •• Alkaline phosphatase • Cardiac Bilirubin • Troponin T •• • CK-MB • GGT •

* In addition several calculated parameters are available.

178 | 179 Back cobas® POC IT solution Bringing it all together

cobas POC IT is responsible for collecting XS Pro

® ® Plus ® results from POC analyzers that are ® ® Plus and Plus and sprint ® ® ­distributed across hospitals and primary care centres. cobas b 101 Reflotron Combur Combur (visual strips) TROP T sensitive (visual strip) cobas h 232 Accu-Chek CoaguChek Accutrend Inform II CoaguChek Reflotron cobas b 123* cobas b 221* Urisys 1100 Hepatology The cobas POC IT solution brings all POC GOT (AST) • information together to provide oversight GPT (ALT) • via your POC program. Furthermore, it Pancreatic amylase • ­provides you with the insight required to Urobilinogen • Renal and urine ensure compliance and the long-range Bilirubin • •• view to plan for improvements and expan- Your benefit Creatinine • sion in the future. Coordinated user management Erythrocytes (Hb) • • • A central point of control for all POC Glucose • •• Roche is committed to assisting POC ­testing devices and users ensures result Ketone • • Coordinators­ with powerful tools required security Leukocytes • • to effectively­ manage POC testing, improve • Most efficient customizable online e- Nitrite • • workflows and meet accreditation and learning with automatic operator recerti- pH • • Protein • • ­regulatory requirements around the world. fication saves a significant amount of time Specific gravity • • Urea (BUN) •• Proven open connectivity to a wide menu Innovative functionality Uric acid • of POC devices gives you the freedom of • Over a decade of collecting user input Urobilinogen • • choice to grow your POC program. and workflows has resulted in a high level of innovation that are firsts on the market

* In addition several calculated parameters are available. Open connectivity at its best

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www.cobas.com

such as true wireless communication and • Connects the full Roche POC portfolio cobas® POC IT solution observed competency on-board POC ­including Accu-Chek Inform II, Coagu- aratr ­devices, as well as positive patient ID – Chek XS Plus and Pro, cobas h 232, irati te ensuring ­patient safety cobas b 101, Urysis 1100, cobas b 121 system, cobas b 123 POC system and Local service and support cobas b 221 system. • Quick and easy access to Roche service personnel in your time zone and language cobas academy ce tlie ca ca ca provides efficient turnaround time for • With cobas academy you can customize ca ert e li C te your questions and ensures maximum eLearning courses and deploy training ­uptime for the systems content on your intranet, and also allow user re-certification automatically – the Proven commitment system will also automatically lock out • The cobas® POC IT solutions are proven ­users who are not certified until they have to perform in over 1,450 systems in > 50 completed the required training. countries with 70,000 connected devices. erec tatiet eeral erati • Including over > 50 Roche and non-Roche cobas bge link eartet eartet ar r POC devices – with a long-term commit- • The cobas bge link software gives you ment to enhancing value for patients and complete and easy remote management POC coordinators missing period of POC blood gas analyzers, allowing you to view and control device operations Product characteristics ­simply and efficiently. cobas IT 1000 application • cobas IT 1000 application gives you com- cobas eServices plete management of POC testing, includ- • Gives your local Roche experts remote ca acae eleari ing remote configuration and control of access, enabling them to quickly and ­devices, user management and LIS/HIS ­efficiently answer your questions in your ­interfacing from a single point of control time zone and language.

182 | 183 Back cobas® infinity POC mobile NEW Always with you www.cobas.com

cobas® infinity POC mobile is a mobile Automate Operator Management Product characteristics app for iOS and Android devices, which The POCC or Nurse Educator can easily Usability has been at the core of the design works in conjunction with cobas IT 1000. review and update operator training status, process and cobas® infinity POC mobile It is designed to help POC Coordinators quickly identifying those operators has been independently rated for usability, (POCCs) complete key tasks whilst on the go. with expired or soon to expire certificates. scoring extremely highly. The product has been designed from the bottom up to be Due to the nature of the testing that they Act on What’s Important easy to use from a mobile device. support, a POCC does a lot of their work With cobas® infinity POC mobile, a POC while “out and about” around hospital Coordinator can monitor overall performance cobas® infinity POC mobile enables the locations. Some of their time is spent at of POC testing and spot any issues that need POCC to easily carryout key workflows their desk, some walking around and to be dealt with quickly and easily. whilst on the move: for many tasks, they need to find a PC in • Device replacement order to access a desktop. • Device relocation • Checking device status This dictates how POC Coordinators work, • Adding a new operator and limits productivity. cobas® infinity • Editing existing operator details POC mobile empowers the POCC, freeing • Checking operator training status them from their office and enabling themto: • Export a list of operators requiring training save time managing devices, automate • Update operator training status operator management and act on what’s important. Technical requirements • cobas® IT 1000 v2.04.01 or higher and Your benefit networked mobile device Save Time Managing Devices • iOS 7 or higher The POCC can easily monitor device con- • Android 4.1 or higher nectivity and QC status. Enabling them • Mobile device on hospital network to quickly identify where they are needed • (VPN for remote connection) for problem solving.

184 | 185 Back cobas® bge link software Central control of your Roche blood gas www.cobas.com and analyzers

The cobas bge link software provides Your benefit Product characteristics complete remote management and control Save time • Information on analyzer status, parameters, of blood gas instruments from one work- • By not having to walk to each analyzer, reagents and reports in a clearly arranged station. with continuous remote status monitoring layout of your blood gas and electrolyte systems, • Management of quality controls and This valuable tool allows the complete from the laboratory ­calibration cycles ­management of all cobas blood gas • Clear presentation of patient results ­analyzers that are connected to a ­hospital Improve analyzer uptime ­measured with the blood gas and network. The cobas bge link ­software • With effective remote troubleshooting ­electrolyte systems from Roche can improve workflow efficiency, freeing and remote control of analyzer functions • Remote control of calibrations, cleaning up valuable staff time and improving (e.g. calibrations, QC, cleaning cycles, cycles and test functions ­service to clinicians in critical care settings. test functions) • Initiation of quality control on the blood gas and electrolyte systems from Roche Increase confidence and security (AutoQC®), can be initiated from the • With remote monitoring of analyzer ­laboratory performance and quality while offering • Levy-Jennings overview of QC history a clear and comprehensive audit trail and trends • Extensive data management possible through integration into cobas® POC IT solution

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186 | 187 Back cobas b 221 system Convenience for your critical care testing www.cobas.com

Blood gas analysis is considered the most Your benefit important tool for diagnosis in critically Fast diagnosis ill patients. Analyzers should deliver rapid • Results in less than 2 minutes to support and reliable results, be easy to handle and timely clinical decision making ­require little maintenance. Our cobas b 221 system offers these features – and a flexible Flexibility of testing configuration which can meet your specific • Comprehensive parameter menu to meet requirements for critical care testing in high varying department needs throughput departments. Confidence in result quality • Lab-quality results where and when Product characteristics • Trending acid-base maps to support you need them • Throughput: up to 50 samples/hour ­clinical decisions • Time to result: less than 2 minutes with • Reagent tracking Improved uptime whole-blood sampling • Customizable features include a user-­ • Long-life, maintenance-free ­electrodes • Optional module for automatic quality control definable display and two types of sample and minimal preventative maintenance • Three different parameter combinations application (see table below) including glucose, • Connectable to network via the cobas® ­lactate, urea and bilirubin bge link software for remote control • Durable, low-maintenance sensors and to the cobas POC IT solution for • Easy-to-use touchscreen and intuitive comprehensive data management user interface

cobas b 221 system Versions 2 4 6

pH/blood gas (PO2, PCO2, pH)/CO-oximetry    Electrolytes (Na+, K+, Ca2+, Cl-)/hematocrit   Metabolites Glu/Lac  Metabolites Glu/Lac/Urea (BUN)  Bilirubin   

cobas b 221 system

188 | 189 Back cobas b 123 POC system Allowing you to focus on patient critical care www.cobas.com

The cobas b 123 POC system is a mobile, Your benefit Product characteristics cartridge-based, critical care analyzer Easy to use • Throughput: 30 samples/hour ­designed for POC testing. With flexible • Intuitive graphical user interface, touch- • Integration of clot prevention features to configurations and a throughput of up to screen and graphically guided instruc- ensure patient care without interruption 30 samples per hour, the cobas b 123 POC tions allow handling steps to be learned and cost-efficient operation system can easily be customized to the in minutes and simplify the training of • Optional mobile cart, battery operation clinical needs of the ICU, ER, NICU, OR*, POC users and wireless connectivity enables ­dialysis units or the laboratory. ­instrument to be operated wherever it Safe is needed The operator-friendly system offers easy • Access control, clot prevention, data • Variety of sample types: whole handling and requires no preventative management including QC, remote blood,dialysis solution, QC solutions • Trending acid-base maps to support maintenance, reducing analyzer downtime. ­control to increase analyzer uptime (both aqueous and blood-based) ­clinical decisions • Connection to cobas® bge link software • Fluid pack – sizes 200, 400 or 700 samples Rapid results and cobas POC IT solution • Near-patient, whole-blood sampling pro- • Automated user management through vides results in only 2 minutes to support cobas­ e-learning timely clinical decision making

Flexibility and scalability cobas b 123 POC system Versions • Allows clinically relevant and cost-efficient 1 2 3 4     POC testing including quality control pH/blood gas (pO2, pCO2, pH) Electrolytes (Na+, K+, Ca2+, Cl-)/Hematocrit     Metabolites Glu/Lac     Bilirubin  

Co-oximetry (tHb, O2Hb, HHb, COHb, MetHb, SO2)   Auto QC  

Plus an extensive range of calculated parameters.

* , emergency room, neonatal cobas b 123 POC system ­intensive care unit, operating room.

190 | 191 Back Accu-Chek ® Inform II solution Safe for patients. Simple for professionals. Efficient for hospitals.

Roche offers a comprehensive solution Your benefit Product characteristics for professional testing of blood glucose Assured patient safety Assured patient safety in hospitals. Blood glucose testing is • The Accu-Chek® Inform II solution • Infection control with an integrated an important standard of medical care brings laboratory safety standards product design of the meter, the in hospitals. to bedside glucose testing and strips and the lancets ­ensures safety for patients and users • Improved clinical decision making The Accu-Chek® Inform II system and with reports of actionable data per the cobas infinity POC IT solutions together Premium quality of results user needs support Point of Care coordinators, • Enables POC testing to meet the physicians, nurses, IT experts and infection highest lab standards when non- Premium quality of results control managers to better manage laboratory experts conduct glucose • Lab standards met with lot-by-lot their complex working tasks. testing calibration and traceability to NIST • High accuracy with proven Automated re-certification repeatability and reproducibility, • Of device users and many other 190+ interferences tested ­automated job tasks centralize the decentralized Point of Care traffic Automated re-certification efficiently • POC workflow automation with automated user re-certification By your side support and notifications • Is a given for continued success • Access and action of test results, with your hospital blood glucose operator performance, and system solution – provided by the market issues on the go leader in hospital glucose testing By your side support • More than 20 years of experience in service and support, with over 150,000 meter placements in the world and a broad expertise

Accu-Chek Inform II system in ­system installation, analysis, consultancy and user training

192 | 193 Back cobas h 232 POC system Facilitate your clinical decisions with rapid results www.cobas.com

Portable and easy-to-use, the cobas h 232 Your benefit Available parameters system helps frontline healthcare providers Fast and reliable patient stratification to quickly make a confident decision whether • Flexible: Suitable for use in pre-hospital Test Measuring range Time to results Clinical utility to admit, discharge or transfer a patient settings and ER for early triage of patients Troponin T 40 – 2,000 ng/L 12 min Identification of patients with suspected acute at high risk of mortality presenting with acute , dyspnea • Quickly ready-to-use: Requires no sample NT-proBNP 60 – 9,000 pg/mL 12 min Aid in diagnosis of patients with suspected heart or other symptoms suggestive of acute preparation or lengthy setup procedures failure, in monitoring of patients with compensated left ventricular dysfunction and in risk stratification cardiovascular disease. • Reliable: Results comparable to Roche of patients with acute coronary syndromes laboratory methods available in maximum CK-MB 1.0 – 40 ng/mL 12 min Diagnosis of acute coronary syndrome and myocardial Thanks to its compact design, the cobas h 12 minutes infarction, assessment of re-infarction D-Dimer 0.1 – 4.0 µg/mL 8 min Exclusion of deep vein thrombosis and pulmonary 232 can easily be deployed near the POC embolism patient where space is tight and mobile use Safety Myoglobin 30 – 700 ng/mL 8 min Early marker of myocardial damage to assist is required, such as ambulances, general • Operator ID entry and lockout to ensure in diagnosis of acute coronary syndrome and myocardial infarction practitioners office, emergency room (ER), use by authorized staff or a designated lab area. • Patient and user ID to ensure correct documentation of test results • Quality control lockout

Control and traceability • Connection to the cobas® POC IT solution allows extension of the testing network and ensures control of operators and quality assurance from the central laboratory • Automatic recertification of operators through cobas academy to ensure use by trained operators only cobas h 232 POC system Optional integrated bar- code scanner and external printer for greater safety and record keeping

194 | 195 Back Roche CARDIAC® Trop T Sensitive test Visual test for the rapid diagnosis www.cobas.com of myocardial infarction

Many patients seek medical attention only Your benefit Product characteristics hours or even days after the onset of chest Highly versatile • Qualitative detection of troponin in pain, especially on weekends. With the • Suitable for use in different clinical ­anticoagulated (EDTA or heparin) venous Roche CARDIAC Trop T Sensitive test you ­settings, e.g. emergency room, GP office whole blood can make a diagnosis even several days or ambulance • Reaction time: 15 min. (up to 10 – 14 days) after ­myocardial dam- • Positive result from a threshold (cut-off) age occurs. Fast results of 100 ng/L • Reliable yes/no result in 15 – 20 min. • Storage at 2 – 8° C (refrigerator) The Trop T Sensitive is a visual troponin T • Test can be used immediately after test. Since it requires no system it can be Easy handling and portability ­removal from the refrigerator easily deployed in rural areas near the point • Simple application that can be used • Storage for 1 week at room temperature­ of patient care, at the bedside, in triage ­anywhere (15 – 25° C) bays, emergency service areas, ambulances • No sample preparation • Roche CARDIAC Trop T Sensitive is or a designated lab area. The Trop T Sensi- • Device independent ­available in 5 and 10 pack sizes tive test is designed for qualitative deter­ mination of cardiac troponin T in the blood Reliable qualitative measurements and elevated levels indicate acute mycardial • Proven test strip technology infarction. Cost-effective Results from a large prospective clinical trial* • Requires no external measurement ­system in Denmark indicate that implementation of • Requires no special training qualitative pre-hospital troponin T testing in the ambulance vehicle by paramedics is On the spot rule-in acute myocardial feasible in most patients, including non-ST infarction segment elevation myocardial infarction • Specific cardiac marker – A positive result (NSTEMI) patients whose condition is not indicates myocardial damage detected by the classical electrocardiogram. • Even if characteristic ECG changes are missing, a positive Roche CARDIAC Trop T Sensitive test with a non-ST-elevation * Sørensen, J.T., Terkelsen, C.J., Steengaard, C.,… Prehospital troponin T testing myocardial ­infarction (NSTEMI) can aid in the diagnosis and triage of patients with suspected acute myocardial infarction. the treatment decision Am J Cardiol. 2011 May 15;107(10):1436-40.

196 | 197 Back CoaguChek® XS system Coagulation self-testing made easy www.CoaguChek.com

The CoaguChek® XS system is a convenient, Your benefit Product characteristics portable and user-friendly instrument for Fast, reliable results • Test principle: Electrochemical deter­ ­monitoring oral anticoagulation therapy. • Accurate PT/INR results in one minute mination of the Prothrombin time (PT) It determines the INR value (International • Built-in quality control checks every strip ­after activation Normalized Ratio) from a drop of capillary automatically of coagulation with human recombinant whole blood – simple, precise and reliable. • Lab-equivalent accuracy precision1 thromboplastin • User interface: Icon-based LCD display; The CoaguChek XS system is ready for use Simple fingerstick test on/off, mem and set buttons anywhere at any time. Patients can use • Most patients prefer having a small drop • Memory capacity: 300 test results with it for self-monitoring at home or while on of blood (just 8 μL) taken from a finger- date and time vacation.­ stick to having blood drawn from a vein3 • Sample types: Fresh capillary or anticoagulant-free venous whole blood Improved patient outcomes • Easy blood application: top- or side • Frequent testing allows side effects to be ­dosing minimized and increases the time spent • Measuring range: within the therapeutic range 2 INR: 0.8 – 8.0 %Quick: 120 – 5 Seconds: 9.6 – 96 • Data transfer: Infrared interface

1 Kitchen, D.P., Munroe, S., Kitchen, S., Jennings, I., Woods, T.A.L., Walker, I.D. (2008). Results from the first year of an external quality assessment programme for the users of CoaguChek XS and CoaguChek XS Plus for monitoring INRs. British Journal of Haematology, Volume 141 Supplement 1: P188. 2 Heneghan, et. al (2006). Lancet, 367; 404-411. 3 Woods, K., Douketis, J.D., Schnurr, T., Kinnon, K., Powers, P. et al. (2004). Patient preferences for capillary vs. venous INR determination in an anticoagulation clinic: a randomized controlled trial. Thromb Res 114(3), 161-165.

198 | 199 Back CoaguChek ® Pro II system Delivering life-saving care with www.CoaguChek.com immediately actionable coagulation results at ALL points of care

CoaguChek® Pro II is the clinically vital point- Your benefit Product characteristics of-care coagulation testing device. In Achieve greater insight into patients’ • Test principle: Electrochemical deter­ addition to monitoring oral anticoagulation coagulation status with the ability to measure mination of the PT and aPTT time after therapy, the Prothrombin Time (PT) and aPTT and PT, and gain a clinically vital activation of coagulation cascade activated Partial Prothrombin Time (aPTT) tool in coagulation care. • Approved for use with capillary, venous, tests will help in the determination of and arterial whole blood factor deficiencies and other coagulopathies Enhanced connectivity through wireless • User interface: large TFT color touchscreen; in several point-of-care locations. technology and a unique QR code screen icons allow intuitive operation feature can result in fewer errors, increased • Memory capacity: 2,000 test results The enhanced connectivity options allow safety, and a streamlined workflow. with date and time and 4,000+ patient for immediate access to patients’ data via and operator ID lists their electronic health records because Ease of implementation with little training – Integrated 2D barcode reader for wireless technology ensures fast, accurate and ease of use with results automatically entering user/patient ID and lot transmission so that workflow will be more transmitted to patients’ electronic records numbers of controls streamlined and results will be available for facilitate the use of CoaguChek Pro II in more • Automatic code chip identification to immediate treatment decisions. places for more patients. match lot-specific information with test strips in use Convenient, portable and user-friendly, – 2 level Liquid control available for the CoaguChek Pro II delivers precise and dedicated QC requirements reliable results from just a drop of blood. • Enhanced data management capabilities: – WLAN-enabled measuring device The CoaguChek Pro II succeeds the connecting to industry standard POCT1-A CoaguChek XS Plus and CoaguChek XS Pro or Roche internal protocol– complete systems and is intended for professional use. documentation of results – Unique QR Code feature allows effortless, real-time transmission of patient data from any location to the customer’s data management solution without the need for POCT1-A communication capability

CoaguChek Pro II

200 | 201 Back Accutrend® Plus system Screening for cardiovascular risk factors www.cobas.com

The Accutrend Plus system is a flexible, Your benefit Product characteristics hand-held point-of-care device for the key On the spot results • Convenient determination of cholesterol, parameters used to detect cardiovascular • Point-of-care lipid testing can substantially triglycerides, glucose and lactate using disease: improve identification and management of capillary blood • Total cholesterol dyslipidemic patients in primary care • Positive control strip and parameter • Triglycerides • Make immediate recommendations ­recognition are used for calibration • Glucose and lactate ­regarding lifestyle or treatment, leading to • Test strips can be stored at room improved patient compliance and loyalty ­temperature This cost-effective, all-in-one device • Can store up to 100 different measure- ­provides rapid, yet accurate results. Safety and reassurance ments with date, time and flags • Built-in automatic performance testing • Great precision and accuracy across and meter self-testing for reliable results the measuring range

Ease of use • Simplicity makes device ideal for testing in the physician office or in hospitalsettings ­

Test Measuring ranges Measuring Sample material Sample Operating time volumes conditions mg/dL mmol/L Glucose 20 – 600 1.1 – 33.3 12 sec • Fresh capillary blood 15 – 50 µL 18° – 35° C Cholesterol 150 – 300 3.88 – 7.76 180 sec • Fresh capillary blood 15 – 40 µL 18° – 35° C • Use of heparin-coated pipettes possible Triglycerides 70 – 600 0.80–6.86 max. 174 sec • Fresh capillary blood 10 – 40 µL 18° – 30° C • Use of heparin-coated pipettes possible Lactate 0.8 – 22 mmol/L 60 sec • Fresh capillary blood 15 – 50 µL 5° – 35° or 15° – 35° C • Use of heparin-coated depending on concent- pipettes possible ration of analyte

Accutrend Plus system

202 | 203 Back Reflotron® Plus system and Reflotron® Sprint systems www.cobas.com Flexible testing to support your clinical decisions

The Reflotron Plus system is a single-test Your benefit Product characteristics • Sample volume: 30 µL clinical chemistry system which allows the Reliability • Throughput of Reflotron® Sprint: • Time-to-result: only 2 – 3 min. measurement of 17 parameters from whole • Test results, correlating well with stan- Up to approx. 60 tests/hour (depends on parameter) blood, plasma or serum – including liver dardized laboratory methods and validated • Throughput of Reflotron Plus: • Integrated printer: and enzymes, metabolites, blood in a number of clinical studies even from Up to approx. 25 tests/hour Immediate documentation of results lipids, hemoglobin and potassium. capillary samples • Sample material: whole blood • Barcode reader and/or keyboard • No storage concerns due to excellent test (capillary and venous) plasma or serum for patient and sample ID input Immediate and reliable test results ensure strip stability quick performance and verification of the • Little waste and almost no maintenance Covering a wide range of daily routine and emergency testing diagnosis without delay. Faster clinical decision making cle ieae eia The system is suitable for primary care • Quick time to result ­settings, as a back-up system in hospitals • No reagent preparation and private labs, at screening sites and for ii etali irer e ieae health check-ups.

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Reflotron Plus system Reflotron Sprint system

204 | 205 Back cobas b 101 system Managing diabetes and ­dyslipidemia www.cobas.com at the point of “need”

The cobas b 101 system is an IVD Your benefit Product characteristics test ­system offering HbA1c and a complete Guideline compliant performance • User-friendly with a large touchscreen, ­ tests at the Point of Care. • cobas b 101 system complies with all full keyboard, and multiple languages

Fresh capillary blood, K2 or K3-EDTA venous ­relevant standards and methods (IFCC, ­support whole blood or plasma * can be used. DCCT/NGSP and NCEP)1 • Robust, maintenance- and calibration- free with a wide operating ­temperature The system delivers fast and reliable results Easy and safe operation and humidity range and is intended for professional use in • Direct blood application from a single • Connection to the cobas POC IT solution a clinical laboratory setting or at point-of- finger stick with small volume • External printer or barcode scanner allow care locations. • No calibration needed, maintenance an improved workflow and ­documentation and service-free, graphical guidance • Data download to USB stick or direct to for simplified use PC are possible

Fast turnaround time Disc features • An intuitive 15 min. workflow from • Direct sample application (no capillaries, patient preparation to results display tubes or pipettes are needed) and of both HbA1c and lipid panel requires only very small sample volumes (2 µL for HbA1c, 19 µL for lipids) Parameters and measuring range • Discs are color-coded and clearly ­labelled in the therapeutically important range IFCC: International Federation of Clinical Chemistry to support correct use. Flap for high • HbA1c disc: DCCT: Diabetes Control and Complications Trial ­operator safety – IFCC: 20 – 130 mmol/mol NCEP: National Cholesterol Education Program NGSP: National Glycohemoglobin Standardization • Discs can be stored for more than – NGSP: 4 – 14 % Program 13 months from production at room – eAG ** temperature (2 – 30ºC) • Lipid disc: * Plasma for lipid panel only. – CHOL: 50 – 500 mg/dL ** Calculated – TG: 45 – 650 mg/dL

1 Roche internal verification data – HDL: 15 – 100 mg/dL cobas b 101 system (multi-center evaluation). – LDL, Non-HDL and TC/HDL **

206 | 207 Back

Tissue diagnostics

Ventana Medical Systems, Inc., a member In addition, Ventana offers premier workflow VENTANA of the Roche Group, is one of the world’s solutions specially designed to improve­ leading cancer diagnostic companies and laboratory efficiency and protectpatient ­ Innovative diagnostic instruments is an innovator of tissue-based tests safety. that enable the delivery of Personalized Healthcare to cancer patients. Recognizing the world’s increasing medical High-value assays needs, Ventana focuses on accelerating The founder of Ventana, Thomas Grogan, the discovery and development of new Digital pathology and workflow M.D., Professor of Pathology, University of prognostic and predictive cancer tests Arizona, established the concept of a single, that help enable Personalized Healthcare. complete report covering all aspects of These tests allow pathologists to analyze Companion diagnostics a patient’s case, which helps to improve patient samples at the molecular, cellular survivability. and tissue level to help determine the best Consultative services course of therapy for individual patients. Ventana is passionate about its mission to improve the lives of all patients afflicted For more information please with cancer by developing and delivering visit www.ventana.com medical diagnostic systems and tissue- based cancer tests that are shaping the ­future of healthcare. VENTANA products provide healthcare professionals with a comprehensive solution for the critical steps involved in the analysis of tissue samples.

208 | 209 Back Tissue diagnostics Leading future innovation

Workflow Sample preparation H&E staining* Special stains IHC/ISH staining Digital pathology histology Tissue processing Morphology Protein/DNA tests Scanner and software (IHC/ISH)

6 6 Method

e. g., HER2(4B5) IHC, HER2 Dual ISH VENTANA HE 600 BenchMark BenchMark series iScan scanners and system Special Stains Virtuoso software

1 2 3 4 5

Roche products VANTAGE workflow management software

1 VANTAGE software 3 BenchMark Special Stains instrument • Systems with different capacity available • Industry-leading Companion Algorithm • Workflow solution from sample preparation • Fully automated special stains from to fit small to large laboratories image analysis solution delivers consistent to statistics monitoring baking to staining • Open systems for antibodies and objective results, time after time • Tracking of both samples and monitoring of • Capacity up to 20 slides per run the lab activity to help ensure quality • Individual heater pads 5 Digital pathology 6 Reagents • Workflow consulting to optimise processes • Pre-packed complete detection kits • Comprehensive digital pathology • H&E, IHC *, ISH *, SpSt * solution — from scanning and image • More than 250 antibodies 2 VENTANA HE 600 system 4 BenchMark IHC/ISH automated viewing to customized reporting • Ready-to-use and barcoded reagents • Individual slide staining technology for H&E staining series • VENTANA iScan HT and iScan Coreo • Fully automated H&E staining from drying • Fully automated IHC * and ISH * systems, scanners — combine unprecedented to glass coverslipping driven by easy-to-use barcoded slides ­flexibility, throughput and reliability • Elimination of xylene and alcohol from the and reagents • VIRTUOSO image and workflow H&E process management software — designed for clinical laboratory use

* H&E = Hematoxylin and Eosin, ISH = In situ Hybridisation, IHC= Immunohistochemistry, SpSt = Special stains

210 | 211 Back VENTANA HE 600 system NEW Master the art and science of H&E staining

Histology laboratories face a critical chal- Your benefit Product characteristics lenge — even in today’s high-tech world. Create seamless workflow and • Throughput: 180 – 200 slides per hour • LIS connectivity through the VENTANA H&E slide preparation continues to be a efficiency at mid stain protocols ­workflow solutions touch point and wait point intensive process. • Provides optimal efficiency by reducing • System integration from drying through • CareGiver remote support is an automated The VENTANA HE 600 system is the newest touch points and wait points in the H&E glass coverslipping remote monitoring and diagnostics solu- innovation from Roche Diagnostics that process by consolidating ovens, stainers, • Easily customizable staining protocols tion that enables continuous monitoring ­enables high levels of efficiency, stain and coverslipping into a single system for unmatched staining flexibility and ­remote service for VENTANA HE 600 ­quality, and improved safety, all while • Frees technicians to focus on value added • Enables over 400 customized protocols system ­providing unprecedented flexibility in the activities to optimize staining pathology laboratory – creating better • Barcode tracking provides full chain of ­results for you, your laboratory and your Make every patients slide ­custody patients. a masterpiece • Individual slide staining provides ­unparalleled levels of stain consistency and ­reproducibly to ensure your first slide of the day has the same level of quality as your last • Ready-to-use reagents that are certified and tested for quality to provide consis- tent, high-quality stains

Improved patient and technologist safety • Individual slide staining with fresh ­reagents on every slide mitigates tissue cross-­contamination and reagent carryover in the H&E process • Eliminates xylene and alcohol for the H&E process

VENTANA HE 600 system

212 | 213 Back BenchMark Special Stains Automated slide stainer

The Ventana BenchMark Special Stains Your benefit Reduced risk automated slide stainer brings complete Superior special stains workflow • Individual slide staining mitigates risk for baking through staining to the histology efficiency cross contamination laboratory for special stains, so your lab • Eliminates manual processes and temper- • Ready to use reagents reduces technician can consistently deliver exceptional quality. ature dependencies with automated depar- risk due to exposure to harmful chemicals Productivity features such as random batch affinization and independent slide heating access, as well as full process integration, Product features/specifications including deparaffinization through staining, Consistent quality • Workflow: Fully automated baking, depar- improves turnaround time and optimizes • Enhanced protocol flexibility with expanded affinization and staining of special stains workflow. user selectable options in order to meet • Slide carousel: 1– 20 slides with indepen- pathologists’ preferences dent temperature control for each position Reduce manual processes and improve • Individual slide staining using quality- • Reagent carousel: 25 reagent positions your capabilities by allocating your skilled controlled, ready to use reagents delivers • Slides: 25 x 75 mm, 1 x 3” or 26 x 76 mm laboratory professionals to higher value consistent, high quality results positively charged contributions. • Bulk fluids: Up to 4 bulk fluids in 3 to 6 liter on-board containers • Modularity: 1– 8 BenchMark Special Stains and BenchMark ULTRA systems may be controlled from one host PC Special Stains menu: Special Stains reagents • AFB III • Iron The new BenchMark Special Stains system • Alcian Blue • Jones Light Green brings reproducible, high quality staining • Alcian Blue for PAS • Jones Hematoxylin capabilities by providing ready-to-use, • Alcian Yellow • Light Green for PAS quality controlled reagents. • Congo Red • Mucicarmine • Diastase • PAS • Elastic • Reticulum II • Giemsa • Steiner II • GMS II • Trichrome Blue • Gram • Green for Trichrome

214 | 215 BenchMark Special Stains Back BenchMark IHC/ISH platform Automated slide staining systems

Minimize diagnostic lead time, maintain Your benefit BenchMark system features consistent high quality and streamline Fully automated Unique and innovative technology for workflow in the histology laboratory with • Standardised IHC and ISH staining best patient care by kinetically optimized the BenchMark IHC/ISH instruments. • Dual and triple stains reaction • Individual heater pads The BenchMark GX, BenchMark XT and Flexibility • Liquid coverslip controls evaporation and BenchMark ULTRA instruments automate • Select from over 250 available Ventana integrity all slide preparation steps of immunohisto- antibodies, or use your own antibodie­ s • Full slide coverage with 100 μL chemistry (IHC), fluorescent IHC, in situ • Independent and simultaneous processing • Air vortex mixing ­hybridisation (ISH) and Dual Color Silver • Immediately process STAT and late-­ tests. They have the flexibility you need to Optimal quality BenchMark GX system arriving samples expand your test menu, process more • Independent protocols for each slide • 20 slide positions • Simultaneous IHC/ISH testing on a single­ slides and improve your turnaround time. • Barcoded slides and reagents for case • 25 reagent positions platform ­identification and traceability • Low to medium throughput • Complete batching IHC and LIS or VANTAGE software connection Workflow ISH diagnosis system • Connect multiple systems with a • Higher throughput and faster single computer or add a new system turnaround times BenchMark XT system to existing ones • Increased laboratory productivity and • 30 slide positions • Share reagents and protocols across reduced­ rework • 35 reagent positions ­instruments through Central Management • Medium to high throughput software • Independent or simultaneous processing • Download patient accession and test of IHC and ISH steps information from LIS to slide staining ­system to mitigate data entry errors BenchMark ULTRA system • 30 slide positions • 35 reagent positions • Flexibility to add/remove slides without impacting workflow • Ability to add or remove reagents without BenchMark GX system BenchMark XT system BenchMark ULTRA system ­interrupting cases in process

216 | 217 Back IHC detection Meet your needs and everything beyond

IHC/ISH detection Your benefit Ventana offers a comprehensive menu of OptiView DAB IHC detection optimized detection systems for use with our Ventana BenchMark IHC/ISH automated Increased sensitivity slide stainers, allowing for the identification By increasing the numbers of HRP enzymes of targets by IHC and ISH. at each primary antibody site, OptiView provides unparalleled signal intensity, IHC detection offerings ­empowering you to achieve the level of Choose from a comprehensive menu of ­intensity you desire for even the low-­ ­detection chemistries (biotin and biotin-free expressing antigens. based systems) and stains (DAB and Red) Ventana p63 stained with OptiView DAB IHC de­ tection. Cyclin D1 (SP4) on mantle cell lymphoma for high-quality IHC results: Enhance stain quality with OptiView DAB IHC Detection Kit. • iVIEW DAB Detection Kit The OptiView DAB IHC Detection Kit offers Our synthetic, non-endogenous hapten (biotin streptavidin) advancements in detection technology, system virtually eliminates background, • ultraView Universal DAB Detection Kit ­using a proprietary non-endogenous, even as signal intensity increases, to create • ultraView Universal Alkaline Phosphatase ­biotin-free hapten technology that allows the perfect view. Red Detection for exceptional range in sensitivity with • OptiView DAB IHC Detection Kit ­extremely low background. Using Ventana Customize intensity OptiView detection software with the Unique chemistry and flexible software ISH detection offerings BenchMark IHC/ISH platform provides ­enable greater control to meet preferred Our comprehensive menu of indirect, the ability to optimise testing to achieve a staining intensity. ­biotin-free detection systems and stains ­desired level of sensitivity and improved (Blue, Silver and Red) provides the options turnaround times, with flexible protocols Improve turnaround time you need for high-quality ISH results: and workflow enhancements. Amazing sensitivity and software flexibility • ISH iVIEW Blue Plus Detection Kit allows you to reduce turnaround time by • ultraView SISH Detection Kit 30 minutes or more for most assays. • ultraView SISH DNP Detection Kit • ultraView Red ISH Detection Kit

218 | 219 Back Primary antibodies Over 250 ready-to-use clinical reagents, optimized for use on Ventana staining platforms

Ready-to-use antibodies Lambda, FITC bcl-2 (SP66) CD68 (KP-1), CONFIRM Ventana antibodies, including a world-class novel antibodies still in the research phase. HHV-8 (Human Herpes Virus Type 8) bcl-2 (124), CONFIRM CD71 (MRQ-48) breast panel, cover the pathology world’s Staining analysis is facilitated by advanced (13B10) bcl-6 (GI191E/A8) CD79a (SP18), CONFIRM diagnostic requests. Ventana antibodie­ s antibody performance and multiple detection IgA (Immunoglobulin A) BOB.1 (SP92) CD99 (O13), CONFIRM include IVD/CE-IVD antibodies, as well as technologies. IgA (Immunoglobulin A), FITC c-Myc (Y69) CD138 (Syndecan-1) (B-A38) IgG (Immunoglobulin G) CD1a (EP3622) Cyclin D1 (SP4-R) IgG (Immunoglobulin G), FITC CD2 (MRQ-11) Fascin (55k-2) Breast Cervical a-1-Antichymotrypsin (ACT) IgM (Immunoglobulin M) CD3 (2GV6), CONFIRM FoxP1 (SP133) Actin, Smooth Muscle (1A4) CINtec® PLUS p16/Ki-67 dual stain a-1-Antitrypsin (AAT) IgM (Immunoglobulin M), FITC CD4 (SP35), CONFIRM Galectin-3 (9C4) (Cytology) (E6H4™ and 274-11 AC3) Beta-catenin (I4) CEA (CEA31) Macrophage (HAM-56) CD5 (SP19), CONFIRM Glycophorin A (GA-R2) Calponin-1 (EP798Y) CINtec® p16 Histology (E6H4) Carcinoembryonic Antigen (CEA) MART-1/melan A (A103), CONFIRM CD7 (SP94) Granzyme B (TF3H8-1) Cytokeratin 14 (SP53) Colorectal and Gastrointestinal Melanoma Associated Antigen CD8 (SP57) Hemoglobin A (SP212) Cytokeratin 5/6 (D5/16B4) Beta-catenin (14) CD2 (MRQ-11) (KBA.62) CD10 (SP67), VENTANA HGAL (MRQ-49) E-cadherin (36), CONFIRM BRAF-V600E (VE1) CD3 (2GV6), CONFIRM Melanoma Associated Antigen (PNL2) CD13 (SP187) IgA (Immunoglobulin A) E-cadherin (EP700Y) c-KIT (9.7), PATHWAY CD31 (JC70) Melanoma Triple Cocktail (A103, CD14 (EPR3653) IgD (Immunoglobulin D) Estrogen Receptor (ER) (SP1), Cadherin 17 (SP183) CD34 (QBEnd/10), CONFIRM HMB45, T311) CD15 (MMA), CONFIRM IgG (Immunoglobulin G) CONFIRM CEA (TF3H8-1) CD63 (NKI/C3) Melanosome (HMB45), CONFIRM CD16 (SP175) IgM (Immunoglobulin M) FoxA1 (2F-83) CEA (CEA31) Cytokeratin (34bE12), CONFIRM MITF (C5/D5), CONFIRM CD20 (L26), CONFIRM Kappa, CONFIRM GATA3 (L50-823) CDX-2 (EPR2764Y) Cytokeratin (AE1), CONFIRM Neurofilament (2F11) CD22 (SP104) Lambda, CONFIRM GCDFP-15 (EP1582Y) COX-2 (SP21) Cytokeratin 8 and 18 (B22.1 and B23.1), p53 (DO-7), CONFIRM CD23 (SP23), CONFIRM LMO2 (1A9-1), CONFIRM CONFIRM HER2 Dual ISH DNA Probe Cocktail Cytokeratin 7 (SP52), CONFIRM p53 (Bp53-11) CD25 (4C9) LMO2 (SP51) assay, INFORM Cytokeratin 19 (A53-B/A2.26) Desmin (DE-R-11), CONFIRM Podoplanin (D2-40) CD30 (Ber-H2) Lysozyme HER-2/neu (4B5), PATHWAY Cytokeratin 20 (SP33), CONFIRM EMA (Epithelial Membrane Antigen) S100 (4C4.9), CONFIRM CD31 (JC70) MUM1 (MRQ-43) (E29), CONFIRM HER-2/neu (4B5), VENTANA DOG1 (SP31) S100 (Polyclonal), CONFIRM CD34 (QBEnd/10), CONFIRM Myeloperoxidase IGF-1R (G11) Glutamine Synthetase (GS-6) Ep-CAM (Epithelial Specific Antigen) SOX-10 (SP267) CD38 (SP149) Oct-2 (MRQ-2) (Ber-EP4) Ki-67 (30-9), CONFIRM Helicobacter pylori (SP48), VENTANA Synaptophysin (MRQ-40) CD43 (L60) PAX5 (SP34), CONFIRM p120 (98) MLH-1 (M1) Factor VIII Related Antigen Synaptophysin (SP11), CONFIRM CD45 (LCA) (2B11 and PD7/26) PD-1 (NAT-105) p53 (DO-7), CONFIRM MSH2 (G219-1129) Factor XIIIa (AC-1A1) Tryptase (G3) CD45 (LCA) (RP2/18), CONFIRM SOX-11 (MRQ-58) p63 (4A4) MSH6 (44), CONFIRM Factor XIIIa (EP3372) Tyrosinase (T311), CONFIRM CD45R (MB1) Spectrin (RBC2/3D5) Progesterone Receptor (PR) MUC1 (H23) C1q, FITC Vimentin (V9), CONFIRM CD45RO (UCHL-1), CONFIRM T-bet (MRQ-46) (1E2),CONFIRM MUC2 (MRQ-18) C3, FITC Vimentin (Vim 3B4), CONFIRM CD56 (123C3), CONFIRM TdT TAG-72 (B72.3) PMS2 (EPR3947) C4, FITC Hematopathology CD56 (MRQ-42) TRAcP (9C5) Topoisomerase IIa (JS5B4), Dermatopathology Fibrinogen, FITC ALK1 (ALK01), CONFIRM CD57 (NK-1) ZAP-70 (2F3.2) CONFIRM Albumin, FITC Kappa, FITC Annexin A1 (MRQ-3) CD61 (2f2)

220 | 221 Back Breast cancer diagnostics Empowering clinical confidence

Roche Diagnostics delivers a comprehensive Analytical superiority Lung EGFR L858R (SP125) Prostate suite of ­validated immunohistochemistry • Specific and sensitive rabbit monoclonal ALK (D5F3), VENTANA EMA (Epithelial Membrane Antigen) Androgen Receptor (SP107) c-MET Total (SP44), CONFIRM (E29), CONFIRM Basal Cell Cocktail (34ßE12+p63), and in situ hybridisation diagnostic solutions antibodies, best-in-class probes and Calretinin (SP65), CONFIRM Epithelial-Related Antigen (MOC-31) VENTANA for breast cancer — so you can deliver the powerful detection systems Carcinoembryonic Antigen (CEA) Epithelial-Specific Antigen/Ep-CAM Cytokeratin 5/6 (D5/16B4) right test, with clinical confidence. (TF3H8-1) (Ber-EP4) Cytokeratin 7 (SP52), CONFIRM Testing efficiency Caveolin-1 (SP43) IGF-1R(G11), CONFIRM Cytokeratin 20 (SP33), CONFIRM Our breast cancer predictive diagnostic • Comprehensive breast cancer solution CD56 (123C3), CONFIRM Mesothelial Cell HBME-1 (HBME-1) ERG (EPR3864) CD56 (MRQ-42) MUC1 (H23) EZH2 (SP129) ­offerings (HER2 IHC and ISH, ER, PR) in • Fully automated assays, with digital CEA (CEA31) Napsin A (MRQ-60) p63 (4A4), VENTANA combination with our supporting diagnostic ­pathology and workflow solutions Chromogranin A (LK2H10) NSE (MRQ-55) PSA, CONFIRM assays (Ki-67, p120 and E-cadherin) are p40 (BC28) Cytokeratin (CAM 5.2) PSA (ER-PR8) fully automated on BenchMark IHC/ISH Product characteristics Cytokeratin 5 (SP27) p63 (4A4), VENTANA PSAP (PASE/4LJ) staining platforms that reduce the time to Cytokeratin 5/6 (D5/16B4) Pan Keratin (AE1/AE3/PCK26) Primary INFORM HER2 Dual ISH DNA Probe Cytokeratin 5/14 (EP1601Y/LL002) Antibody result and resources required compared to Cocktail assay Cytokeratin 7 (SP52), CONFIRM PD-L1 (SP263), VENTANA manual or semiautomated solutions. • Brightfield detection allows evaluation Cytokeratin 17 (SP95) SOX-2 (SP76) of HER2 gene status with morphological Synaptophysin (MRQ-40) Cytokeratin 20 (SP33), CONFIRM Your benefit context E-cadherin (36), VENTANA Synaptophysin (SP11), CONFIRM E-cadherin (EP700Y) TAG-72 (B72.3) Clinical superiority EGFR E746-A750 del (SP111) Thyroid Transcription Factor-1 • High accuracy and clinical confidence HER2 (4B5) Rabbit Monoclonal Antibody EGFR (Epidermal Growth Factor (8G7G3/1), CONFIRM in a short turnaround time to identify­ • Clinical confidence with a world-class Receptor) (5B7), CONFIRM Thyroid Transcription Factor-1 (SP141) ­patients other assays can miss HER2 rabbit monoclonal antibody EGFR (Epidermal Growth Factor WT1 (6F-H2) Receptor) (3C6), CONFIRM

Breast carcinoma INFORM HER2 Dual ISH DNA Probe Breast carcinoma HER2 (4B5) positive Score: 3+; Cocktail ­non-amplified; magnification: 40X. magnification: 40X.

222 | 223 Back Cervical disease diagnostics

The Roche and Ventana Medical Systems, Over 100 publications, medical society 1 Darragh, T. M., et al. (2012). Archives of pathology & Inc. (Ventana) cervical cancer portolio recommendations1 as well as a major laboratory medicine, 136 (10), 1266-1297. doi:10.5858/ helps protect women from cervical cancer Pan-European clinical study2 support the arpa.LGT200570. 2 Bergeron, C., et al. (2010). Am J Clin Pathol.133 (3), and from overtreatment. CINtec® prod- scientific and medical value of the CINtec® 395-406.doi:10.1309/AJCPXSVCDZ3D5MZM. ucts, available exclusively from Roche p16 Histology product for use in cervical 3 P etry, K.U., et al. (2011). Gynecol Oncol. 121 (3), 505-509. and Ventana are the only IVD (in vitro biopsy specimens. doi: 10.1016/j.ygyno.2011.02.033. diagnostics) products to detect the overex- 4 Schmidt, D., et al. (2011). Cancer Cytopathol. 119(3), pression of the cellular protein p16INK4a (p16) CINtec® PLUS — Improving accuracy 158-166. doi:10.1002/cncy.20140. 5 W entzensen, N., et al. (2012). Clin Cancer Res. 18, in cervical cytology and tissue specimens. for detecting high-grade disease in 4154-4162. doi: 10.1158/1078-0432.CCR-12-0270. Used adjunctively with available clinical cervical cancer screening Diffuse p16 immunostained cervical specimen demon- information, the CINtec® products empower The CINtec® PLUS Cytology immunocyto- strating a positive CINtec® p16 Histology result you to make informed, confident decisions. chemistry assay provides simultaneous quali- tative detection of p16 and Ki-67 proteins in The over-expression of p16 (a cyclin- cervical cytology preparations. This advanced dependent kinase inhibitor) in cervical combination of biomarkers provides high specimens, detected by CINtec® immuno- sensitivity and high specificity in a single test. histochemistry products, is highly correlated CINtec® PLUS Cytology identifies underlying with oncogenic transformation caused by high-grade cervical disease in cytology spec- persistent high-risk HPV (hrHPV) infections imens and helps identify women with trans- forming cervical lesions (p16/Ki-67 positive) CINtec® p16 Histology – Seeing beyond who need colposcopy.3,4,5 Co-expression of p16INK4a (brown cytoplasmic immu- H&E in cervical cancer diagnostics nostain) and Ki-67 (red nuclear immunostain) within ® * CINtec® PLUS Cytology is a CE/IVD product, intended The CINtec p16 Histology product is part of the same cell demonstrates a positive CINtec® PLUS for clinical use. CINtec® PLUS Cytology is not available a fully automated immunohistochemistry Cytology result for this use in the United States, Canada, China or (IHC) assay for the qualitative detection of the Japan. Check with your local Roche representative for p16 protein on slides prepared from formalin- the availability of products in your region and the applicable fixed, paraffin-embedded cervical biopsies. intended use.

224 | 225 Back Colorectal diagnostics Assist in diagnosis, risk stratification and subtyping of colorectal cancer

The stages and subtypes of colorectal Mismatch repair IHC staining patterns in colorectal cancer cancer vary significantly in prognosis and MMR mutations IHC result MLH1 IHC result PMS2 IHC result MSH2 IHC result MSH6 treatment options, demonstrating a need MLH1 mutation Loss Loss Preserved Preserved for tools that assist pathologists in detecting and subtyping colorectal malignancies.

Ventana offers a comprehensive panel of ready-to-use rabbit and mouse colorectal BRAF V600E (VE1) Mouse Monoclonal Primary Antibody assays, including IHC assays for the four MSH2 mutation Preserved Preserved Loss Loss most common mismatch repair (MMR) Informing clinical decisions proteins, MLH-1 (M1) Mouse Monoclonal Ventana colorectal and gastrointestinal Primary Antibody, MSH2 (G219-1129), tools aid in diagnosis, subtyping and risk CONFIRM MSH6 (44) Mouse Monoclonal stratification with ready-to-use assays Primary Antibody and PMS2 (EPR3947), that include: along with the BRAF V600E (VE1) Mouse • MMR protein and BRAF V600E (VE1) MSH6 mutation Preserved Preserved Preserved Loss Monoclonal Primary Antibody, for use on assays facilitate efficient and cost-effective the fully-automated BenchMark series subtyping within the anatomic pathology IHC/ISH platforms. laboratory • Gastrointestinal IHC assays such as PATH- The Ventana colorectal primary antibodies WAY c-KIT (9.7) Primary Antibody and PMS2 mutation Preserved Loss Preserved Preserved assist in diagnosis, risk stratification and Ventana Helicobacter pylori (SP48) Rabbit subtyping while helping inform clinical Monoclonal Primary Antibody decisions, and are supported by innovative • Highly sensitive and specific rabbit and automation, detection and workflow solutions. mouse monoclonal assays

Powered by the OptiView DAB IHC detection system.

226 | 227 Back Hematopathology diagnostics A comprehensive solution helping you detect and subtype

Hematological cancers vary significantly Comprehensive menu to aid in diagnosis CD30: cornerstone biomarker that helps in both prognosis and aggressiveness, and subtyping inform clinical decisions demonstrating a need for tools that assist pathologists in making confident diagnoses and helping to inform clinical decisions. We offer over 65 cornerstone and novel hemato- pathology ready-to-use reagents, including key IHC antibodies and ISH probes, that aid in the detection of lymphomas, leukemias and other hematopoietic malignancies. bcl-2 (SP66) Rabbit Monoclonal Primary Antibody CD30 (Ber-H2) Mouse Monoclonal Primary Antibody

The dynamic range of Ventana OptiView Ventana hematopathology suite of ready- We are excited to provide you with the refor- DAB IHC detection delivers unparalleled to-use immunohistochemistry (IHC) and in mulated CD30 (Ber-H2) Mouse Monoclonal sensitivity and specificity so you can detect situ hybridization (ISH) assays feature: Primary Antibody. A cornerstone tissue antigens across a wide range of expression • Exclusive assays such as the BRAF V600E marker for lymphoma, CD30 delivers clinical levels. Our hematopathology assays are (VE1) Mouse Monoclonal Primary Antibody confidence by aiding the pathologist in: optimized for use on the fully automated • New products such as SOX-11 (MRQ-58) • Diagnosis of T-cell and B-cell lymphomas Ventana BenchMark IHC/ISH series Mouse Monoclonal Primary Antibody, • Identification of Reed-Sternberg cells in of instruments to maximize quality and CD13 (SP187) Rabbit Monoclonal Primary Hodgkins Lymphoma (HL) laboratory efficiency. Antibody and CD16 (SP175) Rabbit • Diagnosis of Anaplastic Large Cell Monoclonal Primary Antibody Lymphoma (ALCL) • Choice of detection systems that allows visualization of antigens with This reformulation features updated proto- low expression cols for both OptiView DAB Detection and ultraView Universal DAB IHC Detection.

228 | 229 Back Lung cancer diagnostic solutions Driving Personalized Healthcare with key ­markers for detection and subtyping

The statistics associated with lung cancer Our portfolio of products, which includes Gain a clear view by detecting ALK and PD-L1 protein expression clearly demonstrate the aggressive nature rabbit monoclonal antibodies, novel of this deadly disease, Roche Diagnostics biomarkers and detection kits, delivers offers a robust menu of tools to aid in the the high sensitivity and specificity needed diagnosis of patients facing this challenge. from diagnostic assays. “With the introduction of targeted therapies that can result in dramatically different out- Our antibodies are ready to use on the fully comes based on subtype, the importance of automated BenchMark IHC/ISH series accurate classification has been amplified.”1 of instruments, reducing the time-to-­result and resources required with manual or NSCLC stained with VENTANA ALK (D5F3), NSCLC stained with VENTANA PD-L1 (SP263) semi-automated solutions. and OptiView DAB IHC detection with AMP

Differentiating between adenocarcinoma and squamous cell carcinoma VENTANA ALK (D5F3) Rabbit VENTANA PD-L1 (SP263) Rabbit Confidently differentiate between lung ­Monoclonal Primary Antibody Monoclonal Primary Antibody ­adenocarcinoma (ADC) and squamous cell VENTANA ALK (D5F3) is indicated as an aid The VENTANA PD-L1 (SP263) antibody carcinoma (SCC) with four key markers, in identifying patients eligible for treatment is produced against programmed death- including the p40 (BC28) Mouse Monoclonal with XALKORI (crizotinib). It is, therefore, ligand 1 (PD-L1) B7 homolog 1 (B7-H1, Primary Antibody. critical that ALK positive patients are CD274). It recognizes a transmembrane accurately identified. Shaw et al. highlights bound glycoprotein that has a molecular p40 (BC28) Mouse Monoclonal this importance and demonstrates that mass of 45 – 55 kDa. This antibody produces Primary Antibody ALK testing via IHC represents a reliable membranous, and/or cytoplasmic staining. p40 (BC28) is a sensitive and specific anti- Squamous cell carcinoma stained positive with the p40 and cost effective alternative to FISH.3 body for the detection of the p40 (Np63) (BC28) assay using OptiView DAB IHC detection It is indicated as an aid in the assessment protein. In a panel with other key markers Clone D5F3 has been identified as “one of PD-L1 expression in non-small cell lung 1 T acha, D., Yu, C., Bremer, R., Qi, W., Haas, T. (2012). 5 in our portfolio (TTF-1, CK 5/6, Napsin A), Appl Immunohistochem Mol Morphol 20, 201-207. of the most promising antibodies for the cancer (NSCLC) and other tumor types. p40 (BC28) can provide an accurate and 2 Wei, Z., Hui, W., Yan, P., Bo, T., Lei, P., Da-Chuan, Z. detection of ALK rearrangement in NSCLC.” 4 Minca et al. (2013). J Mol Diagn. 15(3). (2014). Np63, CK5/6, TTF-1 and napsin A, a reliable reliable method for differentiating pulmonary In a study of 296 patients with advanced 5 Z ou, W., Chen, L. (2008). Inhibitory B7-family panel to subtype non-small cell lung cancer in biopsy adenocarcinoma from squamous cell NSCLC clinically referred for ALK testing, molecules in the tumour microenvironment. specimens. Int J Clin Exp Pathol, 7(7), 4247-4253. carcinoma.2 the “ultrasensitive” VENTANA ALK (D5F3) Nat Rev Immunol, 8(6), 467-77. 3 Shaw et al. (2011). J Natl. Compr. Canc. Netw. 9,1335-1341. assay showed high correlation with FISH and 100 % sensitivity and specificity.4

230 | 231 Back Prostate cancer diagnostics Connectivity solutions Diagnostic solutions and innovative tools for emerging utility

Our prostate cancer diagnostic portfolio Work confidently with Connectivity Solutions performance, decreased downtime and can give you the confidence you need to from Ventana that help you optimize lab world-class customer support. Your improve patient care. efficiency, patient safety, and equipment instruments are talking; CareGiver remote uptime through direct connections to your support is listening. Empower your lab with our portfolio of bio- Ventana platforms. From remote support markers that deliver increased­ value for men’s to Laboratory Information Systems (LIS) Ventana Connect software solution health. Our antibodies are pre-diluted and connectivity, we have you covered. Ventana Connect software moves critical optimized for use on the BenchMark IHC/ISH information between multiple LIS systems series of automated platforms for efficient, CareGiver Remote Support and Ventana instruments enabling more ­reproducible staining quality. We continue Prostate carcinoma stained with ERG (EPR3864) Rabbit Monitoring your lab’s Ventana instruments efficient workflow. Discover Ventana to develop­ novel biomarkers with promising Monoclonal Primary Antibody in real-time, the Ventana CareGiver remote Connect software. ­utility — such as the EZH2 (SP129) ­Rabbit support software delivers enhanced system Monoclonal Antibody­ and the Androgen­ Re- • Consistently strong nuclear staining allows ceptor (SP107) Rabbit Monoclonal­ Antibody. for easier interpretation • Like high molecular weight cytokeratin ERG (EPR3864) Rabbit Monoclonal 34βE12, p63 is specific and sensitive for Primary Antibody basal cells in the prostate gland Developed for high sensitivity and specificity, the ERG (EPR3864) Rabbit Monoclonal Ventana Basal Cell Cocktail ­Primary Antibody delivers: 34βE12+p63 • Specificity for prostate cancer which may Our Basal Cell Cocktail combines p63 (4A4) aid in detection and diagnosis with 34βE12 to aid in the differentiation of • Ability to identify a molecular prostate benign and malignant prostatic lesions. cancer subtype • Increases the sensitivity of basal cell • High concordance to ERG FISH detection­ • Decreases staining variability Ventana p63 (4A4) Mouse Monoclonal • Offers more consistent basal cell Primary Antibody ­immunostaining The p63 (4A4) antibody empowers you to make informed, confident decisions.

232 | 233 Back VANTAGE workflow solution A proven system for quality to increase patient safety

Today’s histology lab managers are under Your benefit Full and fast control ­increasing pressure to improve laboratory Eliminate redundancies, reduce errors • Locate any specimen, block or slide workflow, sample tracking, quality and • Reduce data re-entry, relabelling and ­immediately patient­ safety. ­labelling errors with “one label, one time” • Ask the VANTAGE system to locate any technology and barcode scanners at patient’s slide, on any instrument, at any VANTAGE solutions have been designed to ­every workstation point in your process — and count on enable histology laboratories to address ­immediate, accurate results these challenges: Lean workflow • Prevent bottlenecks before they happen. Full transparency Our comprehensive solution for histology The VANTAGE workflow solution gives • Populate patient details accurately labs — hardware, software and workflow you a clear view of your lab, so you can • Retrieve patient details with a quick consulting — offers a commanding view of maintain optimal performance ­barcode scan your complex operation from a single • Collaborate with lean histology experts to ­strategic perspective. It is an end-to-end improve your workflow Product characteristics product that automates, streamlines and • Simplify workflow steps • Includes all Ventana connect integrates lab work and information flow • See a comprehensive dashboard of lab characteristics to help provide maximum productivity performance at any time • Cassette verification/identification and improvements to patient safety. The • Identify opportunities to improve quality, • Slide label generation and management ­VANTAGE workflowsolution­ is designed staffing and efficiency • Harmonised unique slide identification using Lean Six Sigma principles and in- • Centralized instrument slide/test status cludes expert workflow consulting support Establish your chain of custody • Specimen chain of custody to help you obtain ­immediate and ongoing • The VANTAGE workflow management • Block/slide tracking and locating workflow benefits. system brings all of our automated • Workflow process report and ­platforms together, creating a chain of workload statistics custody that encompasses your entire lab • QA/QC management and reports • Specimen archive

234 | 235 Back Companion diagnostics Deliver Personalized Healthcare to those who need it

For every ten cancer patients treated, an Partner of choice for companion Helping to deliver the promise average of only half will benefit. For some, diagnostics of Personalized Healthcare the treatment won’t have any effect; others A global leader in tissue-based cancer Tissue diagnostics: no other technology may suffer from serious side effects.1 diagnostics, we provide a premier end-to- captures the anatomical context that helps Ventana Medical Systems, Inc. is working end offering, with expertise at every stage determine patient outcomes and enables at our industry’s forefront to change this from discovery to commercialization. Working Personalized Healthcare: dynamic by customizing therapy to individual together under one roof, Ventana and • Companion tissue tests help determine the patients, helping you to improve diagnostic pharma increase the efficiency and speed best course of treatment accuracy, lab efficiency and patient safety. of developing patient selection biomarkers. • We are committed to expanding our market- • Brings 180+ biomarker projects with a leading HER2 diagnostic franchise VENTANA ALK (D5F3) Rabbit Monoclonal Antibody In collaboration with leading pharmaceutical strong track record — reliably on time • The Ventana ALK IHC Rabbit Monoclonal companies, we identify and develop inno- and on budget Primary Antibody aids in early detection vative companion diagnostics to target • Provides global access through the and treatment decisions for non-small cell those patients who are likely to respond to Ventana and Roche commercial network lung cancer patients specific therapies. Because we recognize and installed base • The majority of the Roche oncology-focused the tremendous potential for these solutions, • Offers a differentiated, broad instrument targeted therapies, currently in late stage we continue to focus on addressing unmet and reagent portfolio clinical trials, have an associated VENTANA medical needs by developing the cutting- tissue companion diagnostic edge tools you need.

INFORM HER2 Dual ISH DNA Probe Cocktail Assay You can be confident that Ventana products, only from Roche, are the right solution to empower you to deliver the highest-quality diagnostic information for patients — today and in the future.

1 Source: Roche Personalized Healthcare brochure, 2011.

236 | 237 Back Digital pathology Virtual consultation, image analysis and education

Roche Digital Pathology is transforming Your benefit Product features the practice of pathology by developing Virtual consultation VENTANA Virtuoso image and workflow innovative technologies that deliver • Maximize pathologist time management software medical value, inform decision making and • Enable flexibility for tumor boards, case • Anytime, anywhere access to slide images improve cancer care. The integrated sharing and collaboration • Optimized digital workflow and decision- solution consists of high-quality scanners, • Enable fast turnaround time for expert making environment image analysis software, image and opinions • Web-based application to support remote workflow management software and • Provide access to sub-specialists consults and image analysis education applications, all working together globally to optimize laboratories. Image analysis VENTANA Companion Algorithm image Digital pathology enables more efficient • Build clinical confidence with US and analysis software VENTANA iScan HT slide scanner and informed treatment decisions for CE – IVD validated Companion Algorithm • US and CE – IVD validated image analysis • Intended for high-volume scanning sites patients — enhancing care by eliminating image analysis software algorithms for the full breast panel: HER2, • Brightfield scanning capability the boundaries of time and distance. • Facilitate consistent, objective ER, PR, Ki-67 and p53 (360 slide capacity) at various interpretations for breast IHC — verified • Semi-quantitative scores for markers magnifications — 20x, 40x by a pathologist — for every patient requiring cell counts • Continuous random access and STAT • Fully validated as part of a systems processing — with no workflow interruption Education approach — includes reagents, staining • Enrich and accelerate learning in a platforms, scanners and software VENTANA Vector education and collaborative environment collaboration software • Allow students to review material anywhere, VENTANA iScan Coreo slide scanner • Support education and collaboration with anytime, from the device of their choice • Intended for low- to mid-volume digital images scanning sites • Standardize content and eliminate sharing • Brightfield scanning capability resources (slides or microscopes) (160 slide capacity) at various • Allow students to review material magnifications — 4x, 10x, 20x, 40x anywhere, anytime, from the device of • Live mode (remotely controlled robotic their choice (mobile-capable on iOS and microscope) Android devices)

Digital pathology

238 | 239 Back

Sequencing solutions

Roche Sequencing provides researchers with sequencing platforms. This portfolio of Clinical research innovative tools for next-gen sequencing products allows researchers to selectively workflow, including instruments, reagents sequence the human exome, human dis- DNA sequencing and target enrichment products. This portfo- ease-associated genes, or genomic lio of next-generation sequencing products regions of interest in a wide range of is driving research advances in cancer, infec- non-human species. The broad portfolio Innovation tious diseases, inherited genetic diseases, of products with complete customization immunogenetics, drug discovery, agriculture, enables researchers to achieve best-in- Sequence capture environmental ecology and more. class target enrichment efficiency and uniform coverage in variant detection. Roche’s 454 Sequencing Systems spear- GS Junior headed the post-Sanger era with the first Roche Sequencing offers researchers a next-generation sequencing system. The clearer understanding of genomic struc- GS FLX+ System andbenchtop GS Junior ture and function in order to understand System offer a unique combination of pow- the impact of genes on biological process- erful next-generation sequencing through- es. As pioneers in sequencing with a rich put and long, accurate read lengths (up to heritage in diagnostics, the Roche Se- 1,000 bp). The systems allow you to move quencing Unit is committed to a future quickly from sample to result with easy- that fosters innovation to provide solutions to-interpret data and dedicated analysis that enable scientific discovery and deliver software. clinical value – We are Changing Science and Changing Lives. NimbleGen SeqCap Target Enrichment Systems are designed to enrich target DNA For more information please regions for a variety of next-generation visit www.roche-sequencing.com

For life science research only. Not for use in diagnostic procedures.

240 | 241 Back Genome Sequencer FLX+ System Sanger-like read lengths – the power of next-generation throughput

Roche’s portfolio of proven DNA sequenc- Your benefit The Genome Sequencer FLX+ System ing and target enrichment solutions are Fast results – sequence with confidence ­advancing research in human health, agri- • Generate 700 million bases Up to 1,000 bp read length – get all the culture, evolutionary biology, and more. per 23 hours run benefits of Sanger capillary sequencing The GS FLX+ System and benchtop GS with the power of next-gen throughput to ­Junior System offer the unique combination More comprehensive data take your research to the next level. Trusted of powerful next-generation sequencing • Take advantage of the Sanger-like read results in over 1,300 publications: throughput and the familiarity of long length up to 1 kb • Identification of a novel arenavirus re- Sanger-like read lengths (up to 1,000 bp). • Includes powerful and easy-to-use sponsible for a series of fatal transplant- Data Analysis SW associated diseases in Australia NimbleGen SeqCap Target Enrichment Sys- • Generation of the first complete genome tems prepare DNA samples for a variety of Widest application range and flexibility and exome sequences from the hunter- next-generation sequencing platforms, al- • Cover all applications gatherer people of southern Africa lowing researchers to selectively sequence • Gain project flexibility by utilizing • Sequencing of rearranged VDJ immune specific human exome and disease-associ- different plate formats, gaskets and receptor loci tracks immune diversity and ated regions. The broad portfolio of prod- multiplex­ identifiers clonal population ucts with complete customization enables researchers to minimize sequencing costs in variant discovery studies. Product characteristics

Throughput 700 Mb per 23 hours run Read length Up to 1,000 bp Consensus accuracy 99.997 % Data processing and Perform data analysis without the need for enterprise scale IT solutions with bioinformatics preinstalled, easy-to-use software tools: • GS De Novo Assembler • GS Reference Mapper-GS Amplicon Variant Analyzer Applications • De novo sequencing • Re-sequencing • Sequence capture/targeted resequencing • Transcriptome analysis • Gene regulation studies • Epigenetic changes For life science research only. • Metagenomes and microbial diversity Not for use in diagnostic procedures. • Ancient DNA

242 | 243 Back GS Junior System The power of next-generation sequencing on your benchtop

The 454 GS Junior System brings the power Your benefit Product characteristics • Reads per run: 100,000 reads of next-generation sequencing technology Integrated next-generation sequencing Research application (on average) directly to your benchtop, opening the door • Established easy-to-use technology • Unambiguously resolve highly complex • Sample input: gDNA, amplicons, cDNA, to a new revolution in genomic research and Roche sequencing expertise genomic regions (e.g., HLA, IgH) or BACs depending on the application sequencing for every day and everyone. • Discover germline or somatic mutations • Computing: HP desktop computer; ­Access to next-generation sequencing will Increased lab productivity in oncology (e.g., EGFR, KRAS, BRAF, All software is point-and-click no longer be limited to large facilities with • Reproducible data, short run times PI3K, BRCA), hematology (e.g., TET2, CBL, the budget and infrastructure previously and complete data analysis solutions RUNX1, RAS), and metabolic diseases GS Junior applications ­required to accommodate the high demands (e.g., CFTR, MODY) • Zoom into critical genomic regions using of the emerging technology. Broad application versatility • Detect low-frequency variants such amplicon sequencing of PCR products • Due to read length, throughput, as rare drug-resistant viral mutations and sequence capture technologies sensitivity and read accuracy (e.g., HIV*) • Quickly perform haplotyping, genotyping, • Throughput: >35 million high-quality, rare variant detection, structural variant ­filtered bases per run detection, and heterozygote calling • Run time: 10 hours sequencing, 2 hours • Analyze disease-associated regions in data processing ­oncology and immunogenetics, or viral • Read length: ≈ 400 bp quasispecies present within infected • Accuracy: 99 % accuracy at 400 bases ­populations in infectiology

An integrated solution – from sample prep to data analysis

GS Junior Titanium Benchtop instrument and computer Data processing Reagents and accessoires and analysis software For life science research only. Not for use in diagnostic procedures.

244 | 245 Back NimbleGen sequence capture Confident and efficient genetic variant detection

Next-generation sequencing (NGS) target Your benefit Product characteristics enrichment enables you to focus on your Most relevant content SeqCap Target Enrichment Systems is a regions of interest in the human genome, • Uniform coverage of your target region, solution-based c­ apture method that enables hence greatly improving variant detection from the leader in custom designs, enrichment of the whole exome or custom- sensitivity, sample capacity and speed to ­building highest confidence in variant er regions of interest in a single test tube results. Compared to other hybridization- ­detection and data reporting with up to 2.1 million overlapping probes. based enrichment technologies on the mar- ket, Roche NimbleGen products provide Proven performance • SeqCap EZ Systems enable enrichment the highest capture efficiency and cover- • Best-in-class capture efficiency, proven for DNA sequencing on a variety of age uniformity available1,2, as a result of its by independent leading researchers year product offerings from whole-exome to ­superior design algorithms and proprietary over year, leading to optimal sample targeted designs. Additional designs are • SeqCap RNA Systems are designed for probe synthesis technology. throughput available for custom developed designs, target enrichment of cDNA or RNA. Prod- or fixed designs agriculture biology, crop ucts are available in a fixed design for Roche NimbleGen sequence capture Maximum convenience genomes, or model organisms. researching long-coding RNA or custom ­products have enabled effective enrichment • Complete and cost-effective enrichment • SeqCap Epi Systems enable enrichment designs can be developed for human or of a wide variety of genome regions from workflow coverage, from one source, of bisulfite treated DNA for epigenomic model organisms. a broad range of sample types for high-­ greatly simplifying your validation process applications of research. Products are • NimbleDesign is a free online tool that fidelity detection of SNVs (single nucleotide available in a fixed design for whole- enables you to quickly and easily design variations), CNVs (copy number variations), exome epigenomic analysis, or custom SeqCap EZ Choice and SeqCap RNA indels (insertions and deletions), transloca- designs can be developed for human or Choice Systems. tions, epigenomic events, RNA transcrip- model organisms. tion and more.

+

For life science research only. 1 Clark, M., et al. (2011).Nat. Biotech.; doi:10.1038/nbt.1975. Not for use in diagnostic procedures. 2 Bodi, K., et al. (2013). J Biomol Tech. Jul;24(2):73-86. doi: 10.7171/jbt.13-2402-002.

246 | 247 Back

Consultancy services

Healthcare budgets are continually being Based on our experience in serving labora- Consultancy squeezed, which means laboratories and tories for IVD testing, and supported by other diagnostic service providers are faced global and local experts, Roche provides Laboratories not just with operational but also commer- consultancy services for all areas of testing, cial challenges. including molecular and tissue diagnostics.

Efficiency Budget cuts, lack of personnel, limited Roche’s mission is not only to help imple- space, attracting new customers and ment an optimal, future-proof solution Future ­promoting the value of diagnostic services but also to work with service providers in – all of these factors have become impor- ­developing a service strategy that is able Quality tant considerations. to cope with the many demands of a ­constantly changing market. Workflow solution cobas Continuous improvement

248 | 249 Back Consultancy services Inspiring continuous improvement

In a climate of deep financial crisis and Your benefit Consultancy process acute competition, laboratories need to • Empower your people to embrace Laboratory service performance evolve their business into a model that ­continuous performance improvement ­improvement: ­allows them the flexibility to react efficiently • Co-derived sustainable solutions with • Identification of strategic goals to a very fast healthcare market dynamic. ­optimized workflow • Analysis of main streams using LEAN • Rapid implementation according to fact management methodology to derive the The Roche consultancy team can help you based concept optimum solution build the right, fact based strategy to • Increase operational efficiency and • Implementation of proposed solution meet both current and future demand. They ­effectiveness through a series of rapid improvement will support you in the implementation • A working environment with harmonised events which will validate the proposed of the strategy by building LEAN efficient prosperity and performance solutions processes and selecting the right equipment • Long term sustainable partnership • Monitoring of improvement through the to precisely match the clinical needs benefit tracker which will indicate the securing a direct transfer of the value of your ­status in concrete KPI’s for each milestone services into outstanding patient outcome.

A structured approach

nin ieen cin Assess on-going performance Scope the project, against KPIs and through define objectives and benchmarking deliverables nif nyi n eie in eenin cfinin e n E Empower staff to Value stream mapping neen ce continually look for of sample journey from f cnin process improvements requesting to results delivery n ine Measure process ieen performance within the value stream maps to identify bottlenecks

eie in nyi Specifically tailored to your service Gap analysis to reveal difference between Pilot and measure recommended improvement plan current state and target objectives Derive improvement plan

250 | 251 Back

Roche DiaLog

The consolidation and growth of medical Digital Services laboratories is leading to ever-more ­complex processes and diagnostics systems Easy are evolving constantly to keep pace. This brings challenges for the people who Simple use them. To make life easier, Roche­ has developed a one-stop solution that makes Engaging every aspect of laboratory management Transparent easier and more efficient. Relevant information Collaboration

252 | 253 Back Roche DiaLog The changing world of diagnostics

Introducing Roche DiaLog ing past orders, delivery notes and invoices Digital Services A single platform designed to give you faster and track the connections among them. and more convenient online access to all the • Inventory Management allows to maintain information and services you need. stock levels always under control for both Roche and non-Roche products. It tracks the Your benefit goods usage and suggests replenishment • Simplicity: one gateway to Roche actions bringing the Inventory to the next • Increased transparency of your ­processes step in terms of control and optimization. • Receive personalized support • Live chat is an additional support channel, • Stay up-to-date providing direct access to Roche support agents whenever needed. Live chat also Product characteristics enables exchanging pictures or docu- Roche DiaLog: One point of entry to all ments to help better explain challenges Roche Diagnostics digital services. Access and resolutions. to Roche with just one login and password from any device (pc, tablet, mobile). Facili- And this is just the beginning. Roche DiaLog tates engaging interaction for a new form of is always evolving, continuously introducing direct two-way communication that’s simple, improvements and new services. always open, personalized and up-to-date. Current offering*: Digital Services are applications to Technical support your core business. Documents

They include: Track & Trace • Technical documents provides instant ac- cess to all documentation to operate instru- Inventory Management ments and reagents. It contains a powerful search-engine and the ability to get notified Live Chat Events News Videos when new documents become available. • Track & Trace provides a comprehensive over- view of all order-related information, includ- *Not all services are available in all countries.

254 | 255 Back Trademarks All mentioned trademarks are owned by or licensed to a Member of the Roche Group

ACCU-CHEK COBAS E INFORM ROCHE CARDIAC Legal statement ACCU-CHEK INFORM COBAS H INNOVATIS ROCHE MICROSAMPLER No warranty and no liability ACCU-CHEK PERFORMA COBAS INFINITY iScan Coreo Au SAFE-T-PRO While Roche is making great efforts to ACCUTREND COBAS INTEGRA IVIEW SEPTIFAST include accurate and up-to-date information, AMPERASE COBAS P LIFE NEEDS ANSWERS SOFTCLIX we make no representations or warranties, AMPLICHIP COBAS S LIGHTCYCLER SYMPHONY express or implied, as to the accuracy or AMPLICOR COBAS U LINEAR ARRAY TAQMAN completeness of the information provided in AMPLILINK COBAS X MAGNA PURE TARCEVA this brochure and disclaim any liability for AUTOQC COBAS Z MGRADE TINA-QUANT the use of it. Neither Roche nor any other AMPLIPREP COMBUR 10 TEST MODULAR TROPT party involved in creating, producing or BENCHMARK COMBUR 7 TEST MODULAR ANALYTICS EVO ultraVIEW delivering this brochure shall be liable in CASY COMBUR 5 TEST MODULAR PRE-ANALYTICS URISYS any manner whatsoever for any direct, CEDEX COMBUR-TEST EVO URISYS 1100 incidental, consequential, indirect or puni- CELLAVISTA CONFIRM MRSA ADVANCED URISYS 2400 tive damages arising out of any errors or CINTEC DISCOVERY NIMBLEGEN VANTAGE omissions in the brochure contents. COAGUCHEK ELECSYS OPTIVIEW VENTANA COASYS COBAS 454 PATHWAY VIRTUOSO Forward-looking information COBAS GENOME SEQUENCER PEGASYS XCELLIGENCE This brochure may contain forward-looking COBAS B GS JUNIOR PRECINORM ZELBORAF information. Such information is subject COBAS BGE LINK GS FLX REALTIME READY to a variety of significant uncertainties, COBAS C HERCEPTIN REFLOTRON ­including scientific, business, economic and financial factors, and therefore actual results may differ significantly from those presented.

The document is not intended to be distributed in the US.

Please check with your local Roche representative on availability of products listed in this document in Other brands or product names are trademarks of their respective holders. your country.

256 | 257 Back Roche Diagnostics test portfolio Roche Diagnostics test portfolio

Valproic Procain- Pheno- Everolimus Phenytoin Acid Primidone amide barbital NAPA Amikacin Lidocaine Lithium Salicylate Sirolimus RSV Methadone ETOH free free Propoxyphene LSD Gentamicin Valproic BENZO Phenytoin EDDP Cocaine Digoxin Acid %Quick PT INR Cyclosporine Tacrolimus Serum Influenza A/B CRP hs Fibrinogen ADPtest Methaqualone Theophylline Tobramycin BENZO MPA Digitoxin D-Dimer TRAPtest RISTOtest COLtest ASPItest LP (a) HEV Quinidine THC BARB MYO NT-proBNP Trop T Trop T-hs Trop I CK CK-MB GDF-15* aPTT PT Quick DRVVT Serum Crystals KET confirm Opiates T-uptake TSH ATIII APC-R LMWH Vancomycin BARB LDL UFH DRVVT VRE Tg Thrombin time Antithrombin screen HBDH Protein S Clarity Nit Oxycodone Parvo B 19 C diff T4 Muc Calcitonin ACETA CARBA AMPH Na Insulin C-Peptide Cortisol ACTH Anti-TSH-R Lactate AMY Protein C Yeast MPX (HIV/ CHOL Color pH Phencyclidine Mg MTB HCV/HBV) T3 HDL APO B APO A1 HbA1c AMY-P Sperm ACP FT4 FT3 Anti-TPO Anti-Tg anti- HCV RNA HBsAg quant HBc-IgM anti-HBs HBeAg LIP BIL Prot MRSA HBsAg Homo- FRUC PC hGH cysteine HIV anti-HBe anti-HBc WNV HIV RNA qual B2MG ERY SG A1MG Uric acid Urea/BUN TP-U/CSF CREA Cystatin C K ALB Micro-ALB HC HBV DNA EC DPX IGF-1* CEA CA 125 AFP AMH DHEA-S E2 FSH LH Progesterone Prolactin SHBG Testosterone (B19V,HAV) IgG CMV DNA HE4 NSEC UBG PIGF CSF hCG+ß hCG fßhCG PAPP-A sFIt-1 Osteo- Vit D Phosphorus RPR Syphilis IgA CA CERU CT/NG calcin total Gluc CSF IgG anti-HCV PTH (1-84) PTH ßXLaps P1NP Rubella IgG CO2 TRIG TP TPLA IgA C4 LEU Syphilis Toxo HPV CRP anti- anti- HIV HIV-Ag Rubella IgM CMV HSV-2 HSV-1 Cl IgM IgM Iron GLDH HAV HAV IgM combi PT IgM C3c ASLO Haptoglobin Toxo IgG Avidity Toxo IgG CMV IgG Avidity CMV IgG Influenza A/B RSV Bacteria Syphilis HTLV-I/II Chagas* IgM Ferritin CSF Transferrin sTfR UIBC Vit B 12 LDH Folate CA 15-3 CA 19-9 CA 72-4 CYFRA 21-1 S100 NSE free free free PSA PSA Pro-GRP SCC EGFR KRAS BCR-ABL BRAF Kappa Lambda IgE ALP NH3 ALT/GPT AST/GOT BIL-D BIL-T CHE GGT light light chains chains Anti-CCP IL6 PCT Preal- Kappa Lambda bumin light light chains chains RF AAGP AAT

Anemia DAT Infectious Diseases Renal Assay Bone Endocriniology Inflammation TDM Assay in different indications * in development Map is not exhaustive, does not include Tissue Ane Diagnostics.mia DAT Cardiac Infectious Diseases Fertility Renal Assay Metabolic Women’s Health Different assay in same indication Map is not exhaustive, status January 2016 Status February 2016 Bone Endocrinology Coagulation Inflammation Hepatology TDM Assay in different Oncologyindications Urine * In development Cardiac Fertility Metabolic Women’s Health Different assays in same indication Coagulation Hepatology Oncology Urine 258 | 259 Not for distribution in the US.

For additional information please contact your local Roche representative.

©2016 Roche

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