Healthcare Industry News:  Roche Diagnostics 

Diagnostics FDA

 News Release - May 28, 2010

Roche Diagnostics Receives FDA Approval for Qualitative Anti-HCV Immunoassay Test on Three Analyzer Platforms

Antibody to hepatitis C virus assay approved for use on Roche stand-alone and integrated systems for low-, mid- and high-volume testing requirements

INDIANAPOLIS, May 28 -- (Healthcare Sales & Marketing Network) -- Roche Diagnostics announced today that the U.S. Food and Drug Administration (FDA) granted Premarket Approval for its Elecsys Antibody to hepatitis C virus (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.

Roche received approvals for the anti-HCV test on three platforms: the stand-alone cobas e 411 analyzer for low-volume testing; and the cobas e 601 and MODULAR ANALYTICS E 170 analyzers, which are modules of consolidated immunoassay/clinical chemistry systems for mid-volume and high-volume testing, respectively.

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.

Roche received FDA 510(k) clearance for another immunoassay in its infectious disease portfolio, Rubella IgM, in April. The Elecsys anti-HCV assay is anticipated to ship in July.

About Hepatitis C virus

Hepatitis C virus, first identified in 1989,(1) is the most common cause of posttransfusion and community-acquired non-A, non-B hepatitis worldwide. Infection with HCV frequently leads to chronic hepatitis and cirrhosis, and is associated with the development of hepatocellular carcinoma.(2) Hepatitis C is primarily transmitted through contaminated blood and blood products and to a lower extent by human body secretions.(3)

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: or

1 Choo Q, et al. Isolation of a cDNA clone derived from a blood-borne non-A, non-B viral hepatitis genome. Science. 1989;244:359-362.

2 DiBisceglie AM. Hepatitis C and hepatocellular carcinoma. Hepatology. 1997;26(3 Suppl 1):34S-38S.

3 Sharara AI, Durham NC. Chronic Hepatitis C. South Med J. 1997;90(9):872-877.

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Source: Roche Diagnostics

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