Monday, Gen-Probe Incorporated (GPRO), a nucleic acid probe-based products maker for clinical diagnosis, revealed the commencement of clinical trial of its Aptima assay for Trichomonas vaginalis - sexually transmitted infection caused by a tiny parasite- on the fully automated Tigris system.
Trichomonas is a sexually transmitted parasite that can cause vaginitis, urethritis, premature membrane rupture in pregnancy, and make women more vulnerable 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.
The company noted that the highly sensitive and specific trichomonas assay is a great way to leverage large installed base of Tigris instruments, as well as the advantages expected from investigational Panther system.
Trichomonas screening is limited presently in part due to limitations in current testing techniques. Testing currently done is via culture methods, indicated as slow and less sensitive than molecular tests, or "wet mount," which requires the microscopic examination of a sample shortly after it is collected.
Gen-Probe said the trial was intended to secure U.S. regulatory approval and expect research and development expenses associated with its clinical studies, as well as those of human papillomavirus - HPV and PCA3 tests, at approximately $30 million in the third quarter of 2009.
Steve Kondor, Gen-Probe's senior vice president sales and marketing said, "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. 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."
The company is expected to enroll around 800 women at about eight trial sites and clinical trial will be concluded in the first half of 2010. Gen-Probe plans to submit 510(k) application to the U.S. Food and Drug Administration for clearance to to market the medical device
GPRO closed Monday's regular trading at $38.51 up$0.05 or 0.13% on a volume of 0/60 million shares on the Nasdaq.
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