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news.Gen-Probe has submitted to the FDA, a supplemental regulatory application for the additional use of the Procleix Ultrio assay to screen donated blood for the hepatitis B virus or HBV.
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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.
Hank Nordhoff, chairman and CEO of Gen-Probe, said: “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 to the FDA are major milestones for our blood screening business, and may further safeguard the US donated blood supply.”