Roche HBV testing
This article was originally published in The Gray Sheet
Executive Summary
Company plans to launch Cobas AmpliScreen hepatitis B virus test within the next few months. The diagnostic received FDA approval April 21 for use as a supplement to antigen testing in whole blood, blood components and plasma. FDA's Blood Products Advisory Committee endorsed the test 15-1 last year (1"The Gray Sheet" Aug. 2, 2004, p. 12). Cobas AmpliScreen is the first HBV nucleic acid blood screening test to be approved in the U.S., Roche notes...