Roche Tests Positive With FDA Panel: Hep B Blood Screen License Endorsed
This article was originally published in The Gray Sheet
Executive Summary
Roche Molecular System's Cobas AmpliScreen hepatitis B virus nucleic acid test for whole blood is sensitive and specific enough to be licensed as a donor screen, according to FDA's Blood Products Advisory Committee
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Roche HBV testing
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...
Roche HBV testing
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...
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