Gen-Probe Incorporated announced that it has initiated clinical trial in US for APTIMA assay for Trichomonas vaginalis on the fully automated TIGRIS system, to receive US regulatory approval.
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.
A highly sensitive and specific trichomonas assay is a great way to leverage our large installed base of TIGRIS instruments, as well as the advantages we expect from our investigational PANTHER system down the road, said Eric Lai, Ph.D., Gen-Probe’s senior vice president of R&D.
The study is expected to enroll nearly 800 women at about eight trial sites and is scheduled to conclude in the first half of 2010. The company intends to submit to the US Food and Drug Administration a 510(k) application to enable laboratories to use its APTIMA assay to test for Trichomonas from multiple female specimen types, in 2010 summer.