SAN DIEGO, Aug. 13 Gen-Probe Incorporated(Nasdaq: GPRO) announced today that the US Food and Drug Administration (FDA)has approved its supplemental regulatory application to use the PROCLEIX(R)ULTRIO(R) assay to screen donated blood for the hepatitis B virus (HBV). TheFDA had previously approved the assay to screen donated blood for HIV-1 andthe hepatitis C virus (HCV).
The assay is now approved to screen donated blood, plasma, organs andtissue for the three viruses in individual blood donations or in pools of upto 16 blood samples. The assay may be run on the enhanced semi-automatedPROCLEIX system (eSAS) and on the fully automated, high-throughput PROCLEIXTIGRIS(R) system.
"Gaining full FDA approval of the PROCLEIX ULTRIO assay is an importantmilestone for our blood screening business," said Hank Nordhoff, Gen-Probe'schairman and chief executive officer. "More importantly, demonstrating thatthe assay intercepts HBV-infected blood donations that older tests miss is animportant scientific finding that may help further safeguard the US bloodsupply. We are grateful to the blood screening centers that participated inthe trials to demonstrate the utility of the assay." The PROCLEIX ULTRIOassay is manufactured by Gen-Probe and sold worldwide by Chiron, a Novartisbusiness.
Based on the full approval of the PROCLEIX ULTRIO assay on the TIGRISsystem, Gen-Probe expects to record a $10 million milestone payment fromChiron as collaborative research revenue in its third-quarter financialresults.
In October of 2006, the FDA approved the PROCLEIX ULTRIO assay to screendonated blood, plasma, organs and tissue for HIV-1 and HCV on Gen-Probe'ssemi-automated instrument system. In May of 2007, the FDA granted a similarapproval to use the assay on the TIGRIS system.
However, the PROCLEIX ULTRIO assay was not approved to screen donatedblood for HBV, as the initial pivotal study for the assay was not designed to,and did not, demonstrate HBV yield. Yield is defined as HBV-infected blooddonations that were intercepted by the PROCLEIX ULTRIO assay, but that wereinitially negative based on serology tests for HBV surface antigen and coreantibodies.
In early 2007, Gen-Probe and Chiron initiated post-marketing studies ofthe PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor-screening claim. Based on the results of this study, Gen-Probe submitted asupplemental Biologics License Application to the FDA in February of 2008.
HBV is the most common serious liver infection in the world and istransmitted through contact with blood and body fluids. HBV infection can leadto liver failure, cirrhosis or cancer. According to the World HealthOrganization, more than 350 million people worldwide are chronically infectedwith HBV. More than one million people die annually as a result of HBVinfections.
PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics,Inc. TIGRIS is a trademark of Gen-Probe.
Gen-Probe Incorporated is a global leader in the development, manufactureand marketing of rapid, accurate and cost-effective nucleic acid tests (NATs)that are used primarily to diagnose human diseases and screen donated humanblood. Gen-Probe has approximately 25 years of NAT expertise, and received the2004 National Medal of Technology, America's highest honor for technologicalinnovation, for developing NAT assays for blood screening. Gen-Probe isheadquartered in San Diego and employs approximately 1,000 people. For moreinformation, go to http://www.gen-probe.com.
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