bioMérieux CONNECTION June 2008 • VOL 5 NO 3 Message from bioMérieux Welcome to the June 2008 issue of bioMérieux Connection. We are pleased to announce bioMérieux has acquired AB BIODISK, based in Solna, Sweden, on June 18, 2008. AB BIODISK’s leading product line, Etest®, is used to when additional information is needed for particular determine the Minimum Inhibitory Concentration (MIC) bacteria or antibiotics. of antibiotics, antifungal agents and antimycobacterial agents. Etest is very complementary to bioMérieux’s bioMérieux is very enthusiastic about adding Etest to VITEK® range for antibiotic susceptibility testing. bioMérieux’s extensive line of microbiology solutions, including the soon to be launched automated solutions Today, VITEK® 2 Technology can cover the majority of for plate streaking (PREVI™ Isola), urine analysis antimicrobial susceptibility testing needs in routine (UF-1000i) and Gram staining (PREVI™ Color Gram). laboratories; Etest is an invaluable tool for handling non-routine exceptions. Etest is commonly used for bioMérieux expects Etest to complement the VITEK testing fastidious, slow-growing organisms and for Technology range, and to expand its offering of quality the detection of certain resistance mechanisms. information and high medical-value results for Etest can be used as a complimentary test method your institution’s needs. z Printed on recycled paper. IN THIS ISSUE NucliSENS® easyMAG™ Microbiology Automation Survey 3 Validated with Both FDA-Cleared 9 Respiratory Viral Assays 10 How Do You WORKSMART? Near-Perfect Workflow: How 6 Kaleida Health’s Microbiology Lab bioMérieux Odyssey Gets Results to the Clinician Faster 11 Company News bioMérieux 360º/365TM 12 2 New Dimensions in Support from diagnosis, the seeds of better health INTRODUCING TM Introducing 360º/365TM As many of you know already, we have a great team of people behind our products. bioMérieux 360°/365 is a comprehensive suite of customer services They work 24/7 to make sure your team that offer personalized support for bioMérieux solutions. 360°/365 is fully trained, equipment is operational encompasses a wide and customizable array of tools, talent and technology and supplies are delivered on time. You focused on meeting customers’ specific service and support needs. may, however, not be aware of all the bioMérieux’s 360°/365 team is committed to delivering top-rated support services offered by this support group, so that both respond to and anticipate customer needs. we are pleased to introduce 360°/365: New Dimensions in Support. From 360°/365 Includes the Following technical and engineering support to order processing, educational training and Support Components: research, the service professionals at the Order Fulfillment Service Contracts heart of 360°/365 are available 24/7 to • Personal phone support available • Cost-effective solutions that make certain your laboratory services team with our call center staff deliver preventive maintenance delivers accurate and timely results in • Customer focused service and corrective actions support of clinical decision making. environment • Coming Soon: 24/7 Web ordering Education and Training Our support team loves to hear new best for reagents and disposables, • PACE accreditation practice tips from customers, as evidenced including real-time order tracking • Training videos by the WorkSmart tips inside this issue. and access to online order history • Key operator hands-on training Please make sure to share your best • Training on-site practices with your service representative; Application Support • Key opinion leader webinars he or she will be happy to add your tips • 24/7 call center • Web training to a future issue. • Quality verification • Workflow analysis Consultation and Research Additionally, we often hear from our • Test results guidance • Bacterial and yeast culture customers that our support professionals submittal service have gone the extra mile to deliver Engineering Support • Collaborative clinical outstanding service. How has your • 24/7 call center microbiology research initiatives laboratory benefited from our support • Multi-level support, call center (BORIS) staff? We’d love to hear your stories! In this ! and field representation and future issues, we will share some • Instrument repair, emergency and of your experiences. preventative maintenance • Installation and upgrades 2 We at bioMérieux are focused on your • Laboratory Information System success. We thank you for your confidence (LIS) support in our products and services, and look forward to our continued partnership with you to improve patient outcomes now and Coming Soon – Online Ordering! in the future. Timely ordering of supplies is a vital component of your laboratory operations. As part of bioMérieux’s 360°/365: New Dimensions in Support, we are pleased to introduce web ordering. To better serve you, our valued customer, bioMérieux is diligently working to provide you the ability to order via the worldwide web any time, anywhere, Frank V. Crout, Ph.D. at your convenience. We’re putting you in the driver’s seat. Executive Director, Customer Support Operations z This order fulfillment option is coming soon – look for details in our next newsletter! z NEW! #32 Smart Disposable Design #22 NucliSENS® easyMAGTM Proprietary Gold-Standard Validated with Both FDA-Cleared BOOM® Technology Respiratory Viral Assays System Supports Automated Nucleic Acid Extraction For Use with Prodesse ProFlu+TM and Luminex xTAGTM RVP Assays Since its market introduction approximately three Gold Standard Nucleic Acid Extraction Chemistry years ago, bioMérieux’s NucliSENS easyMAG has The foundation of the NucliSENS easyMAG is been broadly adopted as an automated nucleic acid bioMérieux’s own BOOM chemistry which is based extraction platform in front of a variety of home-brew Printed on recycled paper. upon the lysing and nuclease-inactivating properties of molecular tests. Laboratories developing their own the chaotropic salt, guanidium thiocyanate, combined nucleic acid-based assays have appreciated the system’s with the nucleic acid-binding qualities of silica. As ability to extract high-quality nucleic acid (particularly a broadly accepted gold standard for nucleic acid that stemming from infectious disease targets) across a June 2008 isolation and purification, bioMérieux has licensed this variety of sample types while delivering an exceptional proprietary technology to several different companies. level of productivity. 3 For development of the easyMAG system, bioMérieux Now, the NucliSENS easyMAG is claimed for use as set its sites on developing a premium paramagnetic a validated nucleic acid extraction method in front particle variation of BOOM chemistry. The result was of both recently FDA-cleared respiratory virus assays. magnetic silica highly optimized for binding both RNA Earlier this year, both Prodesse and Luminex received and DNA from a variety of clinical sample types. The clearance of 510(k) applications for the ProFlu+ and system’s reputation to perform high-quality extraction xTAG RVP assays respectively. Key clinical trial sites bioMérieux Connection of viral nucleic acids from respiratory samples was used to generate performance data for both assays quickly established and now has been confirmed given used easyMAG for extracting viral nucleic acids from its use in the extensive studies connected with these nasopharyngeal samples. FDA-cleared assays. Continued on page 4. [+] #31 Barcoded & Monitored On-Board Reagents Continued from page 3. [-] The First FDA-Cleared Molecular for a broad panel of respiratory Tests for Respiratory Viruses viruses that includes Influenza A (including HI and H3 subtyping), Until recently, laboratories wanting RSV A, RSV B, Influenza B, to offer nucleic acid-based testing Parainfluenza 1, 2, and 3, Human for respiratory viruses were faced Metapneumovirus, Adenovirus with development of their own and Rhinovirus. The company assays which required rigorous estimates that the entire test clinical and analytical validation. process takes approximately Now, these new assays offer 6.5 hours. complete instructions for use and These new assays offer complete instructions for use and enable molecular applications, if needed. A run of 24 samples is completed clinical laboratories to quickly adopt advanced molecular testing in approximately one hour and the eluted nucleic acid is immediately involving much less validation and ongoing quality control measures ready for downstream use. than their home-brew counterparts. The overall design and operation of the easyMAG is unique among enable clinical laboratories to automated nucleic acid extraction quickly adopt advanced molecular Flexibility and Superior Ease devices. The distinctive processing testing involving much less of Use in an Automated method is based upon a stationary validation and ongoing quality Nucleic Acid Extraction System sample concept where the entire control measures than their Even with the NucliSENS® easyMAG™ BOOM extraction procedure is home-brew counterparts. They also supporting these new respiratory performed in a single sample well. provide more information than the assays, the overall flexibility of the This includes sample lysis, binding typical laboratory developed test. instrument will be maintained. of nucleic acid, all washing steps This includes the ability to process and the final elution of reaction- Prodesse’s ProFlu+™ is a multiplex different sample types/volumes and ready nucleic acid. In addition