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News

Gen-Probe seeks FDA approval for blood screening assay for hepatitis B virus

Gen-Probe : 22 February, 2008  (New Product)
Gen-Probe has submitted a supplemental regulatory application to the US Food and Drug Administration (FDA) for the additional use of the Procleix Ultrio assay to screen donated blood for the hepatitis B virus (HBV).
The FDA approved the Assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006.

The company is seeking approval to use the Assay to screen for HBV on both its semi-automated instrument platform and on the fully automated, high-throughput Tigris system.

'Demonstrating that our Procleix Ultrio Assay is able to identify HBV-infected blood donations that serological tests miss and submitting this supplemental Biologics License Application (BLA) to the FDA are major milestones for our blood screening business, and may further safeguard the US donated blood supply,' said Hank Nordhoff, Gen-Probe's chairman and chief executive officer.

Chiron, a business unit of Novartis Vaccines and Diagnostics, markets gen-Probe’s blood screening products worldwide.
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