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FDA Clears Gen-Probe's HBV Assay; Approval Triggers $10M Milestone Payment

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Gen-Probe’s Procleix Ultrio assay to screen donated blood for hepatitis B, the company said Wednesday.
GenProbe said the FDA's approval triggers a $10 million milestone payment from the Novartis subsidiary Chiron, which is the test’s worldwide distributor.
FDA has cleared the test to screen donated blood, plasma, organs, and tissue for HBV in individual blood donations or in pools of up to 16 blood samples. The approval clears the assay for use on the company’s semi automated Procleix system and on the company’s fully automated Procleix Tigris system.
FDA already approved the assay for HIV-1 and hepatitis C on the company’s automated instrument system in 2006, and it cleared the test for the two viruses in 2007 on the Tigris system.
But FDA did not approve the Ultrio assay because the initial study did not demonstrate HBV yield. The San Diego-based company said that after discussions with FDA it worked with Chiron to conduct a study to demonstrate the test’s HBV yield ability, and it applied for clearance again earlier this year.
Gen-Probe’s CEO, Hank Nordhoff, said that showing that the assay detects HBV-infected blood donations “is an important scientific finding that may help further safeguard the US blood supply.”
HBV, which is transmitted through contact with blood and body fluids, is a liver infection that can lead to liver failure, cirrhosis, or cancer.