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Prevention/Epidemiology OraSure's Hepatitis C Test Awaits FDA ApprovalOctober 30, 2008 On Tuesday, OraSure Technologies Inc. announced it had submitted a pre-market approval application to the Food and Drug Administration for a rapid hepatitis C virus test that uses the OraQuick technology platform. The OraQuick HCV test would be the nation's first rapid HCV test, utilize five specimen types, and have a 20-minute turnaround for results, OraSure said. During pre-clinical trials, the prototype was equal or better than currently available HCV tests, the firm said. "We look forward to launching this product in the U.S. in collaboration with Schering-Plough Corporation once FDA approval is obtained," said Douglas A. Michels, OraSure's president and CEO. Morning Call (Allentown, PA) 10.29.2008; Kevin Duffy  This article was provided by U.S. Centers for Disease Control and Prevention. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.
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