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Gen-Probe Begins U.S. Clinical Study of APTIMA(R) Trichomonas Vaginalis Assay on the TIGRIS(R) System
Date:8/17/2009

SAN DIEGO, Aug. 17 /PRNewswire-FirstCall/ -- Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has begun a clinical trial intended to secure U.S. regulatory approval of its APTIMA((R)) assay for Trichomonas vaginalis on the fully automated TIGRIS((R)) system.

"Initiating a clinical trial of our APTIMA Trichomonas vaginalis assay is an important step forward in our efforts to help doctors and laboratories provide rapid, accurate detection of infectious diseases that can harm women's health," said Steve Kondor, Gen-Probe's senior vice president of sales and marketing. "Our Trichomonas assay will employ the same technology as our market-leading APTIMA assays for Chlamydia and gonorrhea, test the same samples, and run on our TIGRIS system, which remains the only fully automated, high-throughput testing system for molecular diagnostics."

Trichomonas is a sexually transmitted parasite that can cause vaginitis, urethritis, premature membrane rupture in pregnancy, and make women more susceptible to infection with HIV-1, the virus that causes AIDS. The U.S. Centers for Disease Control estimate that there are 8 million cases of Trichomonas infection annually in North America, making it even more prevalent than Chlamydia and gonorrhea, the most common bacterial sexually transmitted diseases.

Screening for Trichomonas is limited today due in part to the shortfalls of current testing techniques. Most testing currently is done via culture methods, which are slow and less sensitive than molecular tests, or "wet mount," which requires the microscopic examination of a sample shortly after it is collected.

"A highly sensitive and specific trichomonas assay is a great way to leverage our large installed base of
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SOURCE Gen-Probe Incorporated
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