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Gen-Probe Submits U.S. Regulatory Application for Additional Approval of PROCLEIX(R) ULTRIO(R) Blood Screening Assay
Date:2/21/2008

SAN DIEGO, Feb. 21 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) has submitted to the U.S. Food and Drug Administration (FDA) a supplemental regulatory application for the additional use of the PROCLEIX(R) ULTRIO(R) assay to screen donated blood for the hepatitis B virus (HBV), the Company announced today. The FDA approved the assay to screen donated blood for HIV-1 and the hepatitis C virus (HCV) in late 2006.

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(R) system.

"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 (BLA) to the FDA are major milestones for our blood screening business, and may further safeguard the U.S. donated blood supply," said Hank Nordhoff, Gen-Probe's chairman and chief executive officer.

Gen-Probe's blood screening products are marketed worldwide by Chiron, a business unit of Novartis Vaccines and Diagnostics, Inc.

Background

In October of 2006, the FDA approved the PROCLEIX ULTRIO assay to screen donated blood, plasma, organs and tissue for HIV-1 and HCV on Gen-Probe's semi-automated instrument system. In May of 2007, the FDA granted a similar approval to use the assay on the TIGRIS system.

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
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SOURCE Gen-Probe Incorporated
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