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Roche Qualitative Anti-HCV Immunoassay Test Wins FDA Approval

Roche Diagnostics has received premarket approval (PMA) from FDA for its Elecsys Antibody to hepatitis C virus (anti-HCV) assay, an in-vitro diagnostic test for the qualitative detection of total antibodies to hepatitis C virus in human serum or plasma.

Roche has received approvals for the anti-HCV test on three platforms like 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.

Roche said that 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 has 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.