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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

based on serology tests for HBV surface antigen and core antibodies. Based on discussions with the FDA, Gen-Probe and Chiron agreed to conduct a post-marketing study of the PROCLEIX ULTRIO assay to demonstrate the HBV yield required for a donor-screening claim.

Gen-Probe began this post-marketing study in early 2007. To date, approximately 500,000 blood donations have been screened in the study, and two HBV yield cases have been identified. Data on these two yield cases comprise the foundation of the Company's supplemental BLA.

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.

Trademarks

PROCLEIX and ULTRIO are trademarks of Novartis Vaccines and Diagnostics, Inc. TIGRIS is a trademark of Gen-Probe.

About 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 employs approximately 1,000 people. For more information, go to http://www.gen-probe.com.

Caution Regarding Forward-Looking Statements

Any statements in this press release about Gen-Probe's expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and are forward-looking statements. These statements
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SOURCE Gen-Probe Incorporated
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