Chiron/Ortho Diagnostic Systems
This article was originally published in The Gray Sheet
Executive Summary
Receive FDA product license on June 22 for the Chiron RIBA HCV 2.0 strip immunoblot assay, a supplemental test for the detection of hepatitis C virus. The firms say the assay is intended for use as "an additional, more specific test for specimens found to be reactive in HCV antibody screening procedures." They add that the product is a three-stage test utilizing recombinant HCV antigens that "helps physicians to more accurately diagnose past or present hepatitis C infections" by providing "additional information." The HCV 2.0 is the third HCV testing system to result from the companies' collaboration ("The Gray Sheet" March 16, p. 3). Sales will begin the week of June 28.