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...
You may also be interested in...
Roche Tests Positive With FDA Panel: Hep B Blood Screen License Endorsed
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
WHO Examines Ethical Criteria For Human Challenge Trials Ahead Of Next Health Emergency
The World Health Organization is looking to finalize its guidance on the ethical criteria that should be applied to studies that involve deliberately infecting healthy individuals to speed up research.
Irish Body Sets Out Five-Year Vision Strategy For Off-Patent Sector
With a focus on drug accessibility, supply chain resilience, and a balanced approach to sustainability, Medicines for Ireland “calls to action” with its five-year plan.