Gen-Probe/Chiron file BLA (Biologics License Application) for Procleix Ultrio:
This article was originally published in Clinica
Executive Summary
Chiron and strategic partner Gen-Probe have submitted a Biologics License Application (BLA) to the FDA for the blood-screening assay, Procleix Ultrio. The application seeks to add hepatitis B virus (HBV) testing capabilities to the already-approved Procleix HIV-1/HCV assay tool - which simultaneously diagnoses HIV and hepatitis C (HCV). Gen-Probe says Procleix Ultrio has the potential to reduce the window period between infection and detection of HBV by as much as 40% compared with currently-available tests. The product is already approved in Europe.
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