Qualitative Anti-HCV Immunoassay Test Designed for Use on Three Analyzer Platforms

Assay results, in conjunction with other laboratory results and clinical data, 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.

Roche Diagnostics Corp. (Basel, Switzerland) announced that the U.S. Food and Drug Administration (FDA) granted Premarket Approval for its Elecsys Antibody to 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 using Roche's ECL technology.

Roche received approvals for its 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- and high-volume testing, respectively. 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 2010.

Hepatitis C virus 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. Hepatitis C is primarily transmitted through contaminated blood and blood products and to a lower extent by human body secretions.

Roche is involved in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company with differentiated medicines in oncology, virology, inflammation, metabolism, and the central nervous system (CNS).

Related Links:
Roche Diagnostics