Product Licensing

License application submitted for HIV-1 and hepatitis C, B screening assay

Published in TB and Outbreaks Week, October 26th, 2004

Gen-Probe Incorporated (GPRO) and Chiron Corporation (CHIR) announced that a Biologics License Application (BLA) for the Procleix Ultrio blood screening assay has been submitted to the U.S. Food and Drug Administration (FDA).

The Procleix Ultrio Assay was developed to simultaneously detect HIV-1, hepatitis C virus (HCV) and hepatitis B virus (HBV) in donated blood, plasma, organs and tissue. The companies intend to seek approval to run the test on both the semi-automated Procleix System and on the fully automated, high-throughput Procleix TIGRIS System.

The Procleix Ultrio Assay adds a test for HBV to the previously approved Procleix HIV-1/HCV Assay....

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Source: TB and Outbreaks Week (2004-10-26)

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