FDA grants Premarket Approval for Roche's IgM antibody to hepatitis B core antigen assay

Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) granted Premarket Approval (PMA) for its IgM antibody to hepatitis B core antigen (Anti-HBc IgM) assay for use on the cobas e 601 analyzer, the immunoassay module of the cobas® 6000 analyzer series for mid-volume laboratories. The test represents the final component of the acute panel within the hepatitis test menu for the cobas 6000 series.

The Anti-HBc IgM assay is used for the in-vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma.  The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of an acute or recent hepatitis B virus (HBV) infection. The assay is intended for use with Roche's electrochemiluminescence (ECL) technology, a highly sensitive light detection system that provides excellent low-end sensitivity and broad dynamic measuring ranges.

With this approval, Roche now offers a full selection of hepatitis tests in its immunoassay portfolio:  HBsAg, HBsAg Confirmatory, Anti-HBs, Anti-HCV, Anti-HAV, Anti-HAV IgM, Anti-HBc IgM (approved for cobas e 601 analyzer) and Anti-HBc (approved for MODULAR ANALYTICS E170 analyzer). The combination of full hepatitis menu with the lowest assay duration on the market, the broadest integrated menu and ECL technology allows the Roche total solution to inspire confidence in the laboratory environment. The Anti-HBc IgM assay is also pending FDA approval for use on Roche's cobas e 411 and MODULAR ANALYTICS E170 analyzers. Roche's current analyzer portfolio offers labs short assay duration (9 to 27 minutes) and the broadest test menu available on an integrated platform.  

SOURCE Roche Diagnostics