Gen-Probe Incorporated announces that the US Food and Drug Administration has approved its supplemental regulatory application to use the PROCLEIX® ULTRIO® assay to screen donated blood for the hepatitis B virus (HBV). The FDA had previously approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV).
The assay is now approved to screen donated blood, plasma, organs and tissue for the three viruses in individual blood donations or in pools of up to 16 blood samples. The assay may be run on the enhanced semi-automated PROCLEIX system (eSAS) and on the fully automated, high-throughput PROCLEIX TIGRIS® system.
"Gaining full FDA approval of the PROCLEIX ULTRIO assay is an important milestone for our blood screening business," said Hank Nordhoff, Gen-Probe’s chairman and chief executive officer. "More importantly, demonstrating that the assay intercepts HBV-infected blood donations that older tests miss is an important scientific finding that may help further safeguard the US blood supply. We are grateful to the blood screening centers that participated in the trials to demonstrate the utility of the assay." The PROCLEIX ULTRIO assay is manufactured by Gen-Probe and sold worldwide by Chiron, a Novartis business.
Based on the full approval of the PROCLEIX ULTRIO assay on the TIGRIS system, Gen-Probe expects to record a $10 million milestone payment from Chiron as collaborative research revenue in its third-quarter financial results.