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Roche Diagnostics Showcases New Technology, Interactive Lab Design Experience at Clinical Lab Expo

Wednesday, July 28, 2010 Education News J E 4
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ANAHEIM, Calif., July 27 Roche is featuring a diverse portfolio of diagnostics testing solutions for healthcare professionals in booth #2808 at the AACC/CSCC 2010 Clinical Lab Expo here, July 27-29 - and it's giving them a unique way to see firsthand where their own "dream lab" might take them.

Roche's DreamLab display allows booth visitors to custom-design analyzer systems - right down to module configurations, reagent channels and system throughputs - to help determine the most effective solutions for their own lab. "DreamLab gives lab professionals the freedom to explore what their ideal lab could look like, and do it in a fun, interactive environment," said Randy Pritchard, vice-president of marketing for professional diagnostics-hospital at Roche. "There's never one perfect solution for all labs. But DreamLab can help lab managers find the perfect one for theirs."

The Roche booth will also feature a variety of new technology for laboratory and point-of-care testing, including integrated clinical chemistry and immunoassay analyzer platforms, automation components, information technology solutions, handheld and mobile point-of-care systems, and chemistry, immunoassay and molecular diagnostics tests.

New products that will be featured in the booth include:

cobas® 8000 analyzer series*

Being designed to bring next-generation consolidation to the high-volume testing lab, the cobas 8000 analyzer series is intended for labs processing greater than two million clinical chemistry and immunoassay tests per year. The series consists of four analytical chemistry/immunoassay modules (cobas c 701*, cobas c 502*, cobas ISE module*, and cobas e 602*) that can be configured into 24 unique combinations to fit the needs of a wide variety of testing environments. In addition to having several features new to the cobas analyzer series, the system is being designed to produce an integrated CC/IA menu throughput up to 4,740 tests/hour or serve as a single high-volume automation chemistry platform with a maximum throughput of 8,400 tests/hour while using only a single entry point. The system is also designed to share a common user interface and common reagents with the cobas® 6000 and cobas® 4000 analyzer series, Roche's systems for mid-volume and low-volume testing. Expected availability is August 2010.

* This product is not cleared or available for use in the U.S. A 510(k) submission is pending.

ACCU-CHEK® Inform II System*

Currently pending FDA 510(k) clearance, the ACCU-CHEK Inform II blood glucose monitoring system is designed to introduce several technological innovations to help improve patient safety and care, improve access to data, and enhance system durability at the point of care. Design goals include both wired and wireless connectivity, with no need to dock the meter to transmit patient results wirelessly; test strip underdose detection; small sample size and fast test results; centralized management of test strip lot data; bar code scanning for accurate patient ID confirmation; a new durable meter design for optimal performance and easy cleaning; and connectivity to the RALS®-Plus data management system to allow access to patient data from virtually anywhere in the hospital. Anticipated clearance in the second half of 2010.

* This product is not cleared or available for use in the U.S. A 510(k) submission is pending.

CoaguChek® XS Pro System

The newest member of the CoaguChek XS family of meters, the CoaguChek XS Pro system is a point-of-care anticoagulation monitor with a built-in bar code reader that can automatically scan and capture operator and patient identification information. The bar code reader is designed to help healthcare professionals who monitor patients on warfarin therapy save time and prevent errors that could occur from manually entering the information in conjunction with PT/INR (blood clotting time) testing. Requiring just a small sample of blood - only 8 microliters - the CoaguChek XS Pro system provides test results in about one minute. It uses built-in quality controls, with the option to run two levels of additional liquid controls. The meter can store up to 1000 patient results and 500 optional liquid quality control results, and the operator has the option to enter comments related to either type of result. Introduced in July 2010.

cobas p 501 post-analytical unit

Developed to help streamline a lab's workflow and manage the entire life cycle of a sample tube, the cobas p 501 post-analytical unit is being designed to provide automated storage and retrieval for up to 30,000 sample tubes in a compact footprint (17 linear ft). It is being designed to connect directly to Roche automation, store up to 400 samples per hour in a convenient refrigerated environment, and automatically dispose of samples after a designated period of time. The unit is also being designed to receive sample retrieval requests for add-on tests immediately through integration with the laboratory information system (LIS). Introduced in April 2010.

Elecsys Anti-HCV Assay

The Elecsys Anti-HCV assay is an in-vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma. The anti-HCV assay is an 18 minute test designed for use with Roche's electrochemiluminescence (ECL) technology. Assay results, in conjunction with other laboratory results and clinical information, may be used to aid in the presumptive diagnosis of HCV infection in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis C infection. The test does not determine the state of infection or associated disease. Introduced in May 2010.

Elecsys Anti-HAV IgM assay*

The Roche Elecsys Anti-HAV IgM immunoassay is intended for the in-vitro qualitative determination of IgM antibodies to the hepatitis A virus in human serum and plasma. Used as an aid to detect an acute or recently acquired hepatitis A virus infection, the electrochemiluminescence immunoassay is intended for use on four immunoassay platforms: the Elecsys 2010, MODULAR ANALYTICS E 170, cobas e 601 and cobas e 411 analyzers.

* This product is not cleared or available for use in the U.S. A 510(k) submission is pending.

LightCycler® MRSA Advanced Test

The LightCycler MRSA Advanced Test is a qualitative in-vitro diagnostic test for the direct detection of nasal colonization with methicillin-resistant Staphylococcus aureus (MRSA). The test is designed to aid in the prevention and control of MRSA infections in healthcare settings. It will be performed on Roche's LightCycler 2.0 Instrument with nasal swab specimens from patients suspected of colonization, using Roche's patented real-time polymerase chain reaction (PCR) technology. Designed to offer a convenient, ready-to-use format and flexible batch sizes, the LightCycler MRSA Advanced Test is intended to help ensure the safety and productivity of laboratory staff and provide flexible throughput and accurate and reliable results. Introduced in July 2010.

About Roche

Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with truly differentiated medicines in oncology, virology, inflammation, metabolism and CNS. Roche is also the world leader in in-vitro diagnostics, tissue-based cancer diagnostics and a pioneer in diabetes management. Roche's personalized healthcare strategy aims at providing medicines and diagnostic tools that enable tangible improvements in the health, quality of life and survival of patients. In 2009, Roche had over 80,000 employees worldwide and invested almost 10 billion Swiss francs in R&D. The Group posted sales of 49.1 billion Swiss francs. Genentech, United States, is a wholly owned member of the Roche Group. Roche has a majority stake in Chugai Pharmaceutical, Japan. For more information: www.roche.com or www.roche-diagnostics.us.

All trademarks used or mentioned in this release are protected by law.

For further information, please contact:

Betsy Cox Director, Corporate Communications Roche Diagnostics Corporation Indianapolis, IN (317) 521-3911 betsy.cox@roche.com

SOURCE Roche Diagnostics
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