However, the PROCLEIX ULTRIO assay was not approved to screen donated blood 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 blood donations that were intercepted by the PROCLEIX ULTRIO assay, but that were initially negative based on serology tests for HBV surface antigen and core antibodies.
In early 2007, Gen-Probe and Chiron initiated post-marketing studies of the PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor- screening claim. Based on the results of this study, Gen-Probe submitted a supplemental Biologics License Application to the FDA in February of 2008.
HBV is the most common serious liver infection in the world and is transmitted through contact with blood and body fluids. HBV infection can lead to liver failure, cirrhosis or cancer. According to the World Health Organization, more than 350 million people worldwide are chronically infected with HBV. More than one million people die annually as a result of HBV infections.
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,
manufacture and marketing of rapid, accurate and cost-effective nucleic
acid tests (NATs) that are used primarily to diagnose human diseases and
screen donated human blood. Gen-Probe has approximately 25 years of NAT
expertise, and received the 2004 National Medal of Technology, America's
highest honor for technological innovation, for developing NAT assays for
blood screening. Gen-Probe is headquartered in San Diego and employ
|SOURCE Gen-Probe Incorporated|
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