Roche Amplicor, Cobas HCV RNA Tests Approvable With Conditions - Panel
This article was originally published in The Gray Sheet
Executive Summary
Roche Molecular Systems should include in labeling for the Amplicor Version 2.0 and Cobas Amplicor automated Version 2.0 hepatitis C tests a warning that heparin use could lead to an "HCV not-detected" result, FDA's Microbiology Devices Panel agreed in recommending FDA approval at a July 28 meeting.
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