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Oncology and Pathology COMPREHENSIVE TEST SERVICES

Oncology and Pathology COMPREHENSIVE TEST SERVICES

Oncology and COMPREHENSIVE TEST SERVICES

Your single-source laboratory solution

HEMATOPATHOLOGY - DIAGNOSTIC SERVICES

Comprehensive ● Morphology, , with reflex to IHC, FISH, and/or PCR Hematopathology Analysis as necessary ● Hematopathologist will select testing based on medical necessity ● Prognostic reflex testing using a rules-based approach

Bone Marrow and ● Surgical pathology consultation Peripheral Blood ● Second opinion ● Special stains

Cytogenetics ● Blood ● Bone marrow ● Solid tumor

Flow Cytometry ● Comprehensive / assessment ● ZAP70/CD38 after CLL diagnosis ● CLL-MRD (minimal residual disease) ● Paroxysmal nocturnal hemoglobinuria (PNH) with FLAER

Fluorescence ● More than 46 hematologic fish probes Hybridization (FISH) ● Disease-specific FISH profiles

Immunohistochemistry (IHC) ● More than 80 hematologic IHC antibodies

Reveal® SNP Microarray ● Whole-genome coverage that is more comprehensive than targeted FISH analysis and provides more than 100 times the resolution of cytogenetics for copy number changes ● 2.6 million copy number and allele-specific genomic sites ● Applications in ALL, AML, CLL, MDS, and MM

Next Generation ● IntelliGEN® Myeloid - The 50 panel identifies somatic mutations useful Sequencing (NGS) in providing diagnostic, prognostic, and predictive information for patients with myeloid , including MDS, AML, and MPN.

PROVIDING CLIENTS WITH ACCESS to the latest developments in medical diagnostics, supported by industry-leading technical and professional expertise. HEMATOPATHOLOGY - FISH AND MOLECULAR

Acute Lymphocytic ● ALL FISH profile Leukemia (ALL) ● BCR/ABL1, t(9;22) by FISH and quantitative RT-PCR ● Hyperdiploidy by FISH

Acute Myelogenous ● AML FISH profile ● IDH1/IDH2 mutation analysis by PCR Leukemia (AML) ● CEBPA mutation analysis by PCR ● IntelliGEN® Myeloid by NGS ● cKIT mutation analysis by PCR ● NPM1 mutation analysis by PCR ● FLT3 mutation analysis by PCR ● PML/RARA, t(15;17) by quantitative RT-PCR

Acute Promyelocytic ● PML/RARA, t(15;17) by FISH and quantitative RT-PCR Leukemia (APL)

Chronic Lymphocytic ● CLL FISH profile ● p53 mutation analysis Leukemia (CLL) ● IgVH mutation analysis ● Reveal® SNP Microarray ● Minimal residual disease (MRD) ● TP53 (17p-) by FISH by flow cytometry

Chronic Myelogenous ● ABL kinase domain mutation analysis Leukemia (CML) ● BCR/ABL1, t(9;22) by FISH and quantitative RT-PCR

Follicular Lymphoma ● IGH/BCL2, t(14;18) by FISH

Hypereosinophilic ● HES analysis by FISH Syndrome Disorders (HES) ● FGFR1 ● FIP1L1 ● PDGFRA ● PDGFRB

Multiple Myeloma (MM) ● MM FISH profile ● Plasma -enriched prognostic FISH profile (Includes 1q21 (CKS1B)) ● Reveal® SNP Microarray

Myeloproliferative ● MPN FISH profile ● JAK2 exon 12-15 mutation analysis (MPN) ● CALR mutation analysis ● JAK2 V617F ● IntelliGEN® Myeloid by NGS ● MPL 515 mutation

Myelodysplastic Syndrome ● MDS profile ● IntelliGEN® Myeloid by NGS ● Reveal® SNP Microarray

Non- ● NHL FISH probes (NHL) ● B-cell gene rearrangement by PCR (IgH, IgK) ● MYD88 (L265P) by PCR ● T-cell gene rearrangement by PCR (TRG, TRB)

The Integrated Oncology Advantage SOLID TUMOR

SOLID TUMOR - DIAGNOSTIC SERVICES

Complex Tumor Analysis ● Comprehensive tumor analysis, including differential diagnosis of unknown primary ● Histologic evaluation with the application of IHC, FISH, ISH, and/or molecular testing as necessary to establish a diagnosis

Gastrointestinal Stromal ● BRAF mutation analysis Tumor (GIST) ● CD117, CD34, DOG1 by IHC ● cKIT mutation analysis ● PDGFRA mutation analysis

Immunohistochemistry ● More than 330 IHC antibodies for solid tumor and hematolymphoid neoplasms and FISH ● More than 35 disease-specific profiles of clinically-relevant IHC markers ● More than 75 solid tumor and hematologic FISH probes

Infectious Agents by IHC ● Adenovirus ● Human virus (HPV) tissue and ISH ● Cytomegalovirus subtype (high risk/low risk) ● Epstein-Barr virus (EBER) ● Parvovirus ● Epstein-Barr virus (LMP1) ● PML (JC) virus ● Helicobacter pylori (H. pylori) ● Pneumocystis carinii ● Hepatitis B core and surface antigen ● Toxoplasma (HBcAg/HBsAg) ● Varicella-zoster virus ● Herpes simplex virus (HSV)

Lynch Syndrome (HNPCC) ● Comprehensive diagnostic evaluation ● MLH1, MSH2, MSH6, PMS2 by IHC Tumor Testing for Lynch syndrome, with all necessary ● MLH1 promoter methylation testing directed by our pathologists ● Somatic Tumor MMR sequencing test ● BRAF mutation analysis ● Microsatellite instability (MSI) by PCR

Hereditary Testing ● BRCA ssure® BRCA1/2 analysis ● VistaSeq ® hereditary cancer panels by NGS ● Comprehensive BRCA1/2 analysis ● Hereditary cancer panel (27 NGS ● BRCA1/2 deletion/duplication analysis multi-gene panel) ● Ashkenazi Jewish panel ● Hereditary cancer panel without B RCA1/2 ● BRCA1/2 familial testing of known mutations ● Hereditary cancer specific panels ● Brain/CNS/PNS cancer panel ● Lynch syndrome genetic testing ● and GYN cancer panel ● MLH1, MSH2, MSH6, PMS2 gene sequencing and deletion/duplication ● panel analysis ● panel ● EPCAM deletion/duplication analysis ● Endocrine cancer panel ● MLH1, MSH2, MSH6, PMS2 familial testing ● GYN cancer panel of known mutations ● High/moderate risk breast cancer panel ● High risk colorectal cancer panel ● panel ● Renal cell cancer panel

● Mutation-specific sequencing SOLID TUMOR - PROGNOSTIC/PREDICTIVE/MONITORING

Breast Cancer ● EGFR by IHC ● p53 by IHC ● ER and PR by IHC ● PIK3CA mutation analysis ● HER2 by IHC, FISH and ISH ● Prosigna® breast cancer prognostic ● HERmark® gene signature assay ● Ki-67 by IHC ● Tamoxifen CYP2D6 genotyping

Colorectal Cancer ● Comprehensive predictive panel: ● Microsatellite instability (MSI) by PCR and Gastric Cancer KRAS/NRAS extended panel, BRAF, MSI (PCR) ● MLH1, MSH2, MSH6, PMS2 by IHC ● BRAF mutation analysis ● NRAS extended mutation analysis ● DPD 5-FU polymorphism (exons 2, 3, 4) ● EGFR by IHC and FISH ● PD-L1 by IHC KEYTRUDA® ● HER2 by IHC, FISH, and ISH ● PIK3CA mutation analysis ● KRAS extended mutation analysis ● Thymidylate synthase (TS) by IHC (exons 2, 3, 4) ● UGT1A1 irinotecan toxicity

Gastrointestinal Stromal ● BRAF mutation analysis Tumor (GIST) ● cKIT mutation analysis ● PDGFRA mutation analysis

Immunotherapy ● Microsatellite instability (MSI) by PCR ● PD-L1 by IHC KEYTRUDA® ● MLH1, MSH2, MSH6, PMS2 by IHC ● PD-L1 by IHC OPDIVO® ● OmniSeq AdvanceSM assay ● PD-L1 by IHC TECENTRIQ® ● OmniSeq Immune Report Card® assay

Lung Cancer ● Comprehensive predictive panel: ● KRAS mutation analysis EGFR mutation, KRAS, BRAF, ALK and ● MET amplification by FISH ROS1 by FISH, PD-L1 by IHC KEYTRUDA® ● MET expression by IHC ●  vs. squamous cell ● OncomineTM Dx Target Test - Lung carcinoma by IHC ● PD-L1 by IHC KEYTRUDA® ● ALK (D5F3) by IHC ● PD-L1 by IHC OPDIVO® ● ALK rearrangement by FISH ● PD-L1 by IHC TECENTRIQ® ● BRAF mutation analysis ● RET rearrangement by FISH ● EGFR by FISH ● ROS1 rearrangement by FISH ● EGFR mutation analysis ● EGFR mutation analysis (cobas® v2) in FFPE tissue or plasma

Melanoma ● BRAF gene mutation analysis (V600 E/K)

Neuropathology ● 1p19q by FISH ● IDH1/IDH2 mutation analysis ● MGMT methylation

Pan-Cancer Profiling ● IntelliGEN® oncology therapeutic panel by NGS ● OmniSeq AdvanceSM assay ● OmniSeq Comprehensive® assay ● OmniSeq Immune Report Card® assay

Urothelial Cancer ● PD-L1 by IHC KEYTRUDA® ● PD-L1 by IHC OPDIVO® ● PD-L1 by IHC TECENTRIQ® PRACTICE SUPPORT SERVICES

PATHOLOGY CONSULTATIVE SERVICES

Experienced staff of more ●  ● Molecular pathology than 60 pathologists with ● Dermatopathology ●  the following ● Gynecologic and cervical pathology ● Orthopedic pathology ● Head and neck pathology ● Transfusion /blood banking ● Hematopathology ● Uropathology ● Immunopathology

INTERACTIVE PRODUCTS

PATHways/GOLD ● Secure, web-based client portals for online ● Access to Integrated Oncology’s suite CONNECT® results and reporting of Virtual (TC) pathology products ● Streamlined, flexible work list for real-time ● Correlative reporting for combined test tracking of specimen receipt and results results from Integrated Oncology and client performed tests

Virtual Image ● Whole-slide imaging for IHC cases ● Produce professional reports which can ● Web-based VENTANA® Virtuoso™ include color photomicrographs and application providing digital imaging adhere to CAP/CLIA regulations on IHC for online interpretation and ● Images can be exported to support reporting tumor board reviews ● Supports computer-assisted analysis of Breast Tissue Prognostic IHC using VENTANA Virtuoso’s FDA-cleared algorithms

Virtual Flow Cytometry ● Web-based application providing gated ● Regating capability using FCS Express histograms and flow cytometry data Reader* for online interpretation and reporting ● Ability to produce a single “correlative” ● Enables timely review and interpretation report that incorporates various testing of flow cytometry cases modalities, including client performed testing*

Comprehensive IT and ● More than 700 connectivity solutions that ● Automated printing to in-office color Reporting Solutions integrate >250 EMR, LIS, and PMS systems printers for immediate delivery of color ● Electronic data interfacing of HL7 reports and PDFs ● Value-based care for our clients, bringing ● LabCorp LinkTM web portal simplifies together all your data to improve patient ordering, receiving, and tracking outcomes, manage costs and optimize of laboratory test results, your reporting needs ● Combines clinical and anatomic pathology results into one solution

*Available at Phoenix and Brentwood locations only PRACTICE ENHANCEMENT SOLUTIONS Integrated Oncology provides a robust portfolio of innovative, scalable, and tailored laboratory business solutions to provide customers with options for enhancing their practice.

one laboratory for your entire practice Integrated Oncology – a LabCorp Specialty Testing Group LAB LOCATIONS Arizona More than 541,000 tests performed on 387,000+ Integrated Oncology patients annually 5005 South 40th Street Phoenix, AZ 85040 1,600 contractual relationships with plans, payors, 800.710.1800 • Fax 800.481.4151 and other organizations across the US, Connecticut/New York some of which are on an exclusive basis Integrated Oncology 3 Forest Parkway More than 700 connectivity solutions that integrate Shelton, CT 06484 >250 EMR, LIS, and PMS systems 800.447.5816 • Fax 212.258.2143 North Carolina Menu of more than 550 genetic, pathology, IHC, LabCorp Center for Molecular and FISH tests, including both somatic and Biology and Pathology hereditary testing 1912 Alexander Drive Research Triangle Park, NC 27709 Staff of more than 75 pathologists, PhDs, and 800.345.4363 • Fax 919.361.7798 genetic counselors dedicated to oncology Tennessee and familial cancer testing Integrated Oncology 201 Summit View Drive, Suite 100 More than 95 oncology- and pathology-specific Brentwood, TN 37027 publications and presentations since 2013 800.874.8532 • Fax 615.370.8074

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