Roche Diagnostics gets FDA premarket approval for HCV antibody assay.

INDIANAPOLIS, May 28 /PRNewswire/ -- 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.