UPDATE 1-Roche wins pre-market FDA ok for hepatitis test

Fri May 28, 2010 1:42am EDT

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* Elecsys test detects antibodies to hepatitis C

* Won pre-market approval for test on three platforms

ZURICH May 28 (Reuters) - Roche (ROG.VX) has won pre-market approval from the U.S. Food and Drug Administration for an in-vitro test aimed at detecting antibodies to the hepatitis C virus, the Swiss drugmaker said on Friday.

Roche's 18-minute Elecsys Antibody anti-HCV test would scan for total antibodies in human serum or plasma.

The test may be used in the diagnosis of HCV infections in those with sympthoms of hepatitis or at risk of hepatitis C which is primarily transmitted through contaminated blood and blood products.

Roche won approval for the test on three platforms -- the stand-alone cobas e 411 analyser for low-volume testing, and the cobas e 601 and modular analytics E 170 analysers, which are respectively modules of consolidated immunoassay/clinical chemistry systems for mid-volume and high-volume testing.

The test is anticipated to ship in July, the company said. (Reporting by Lisa Jucca; Editing by Dan Lalor)

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