Gen-Probe submits 510(k) application to FDA for APTIMA Trichomonas vaginalis assay on TIGRIS system

Oct 5 2010

Gen-Probe Incorporated (Nasdaq: GPRO) announced today that the Company has submitted a 510(k) application to the US Food and Drug Administration (FDA) for its APTIMA® Trichomonas vaginalis assay on the fully automated TIGRIS® system.

"Trichomonas is the most common curable sexually transmitted disease in young women, and it can lead to serious health consequences if left untreated," said Carl Hull, Gen-Probe's president and chief executive officer.  "We believe our Trichomonas vaginalis assay will contribute significantly to women's health and provide a convenient tool for physicians and laboratories.  Our assay employs the same technology as our market-leading APTIMA tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system.

"In addition, this regulatory application represents the third of five that we plan to complete in the United States this year.  Taken together, we expect these new products to start an important new sales growth cycle for the Company."

Trichomonas is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women.  If left untreated, complications can include premature labor, low-birth-weight offspring, and premature membrane rupture in pregnancy.  Studies have shown that Trichomonas infection also makes women more susceptible to infection with HIV-1, the virus that causes AIDS, and contributes to increased persistence of the Human Papillomavirus (HPV), which causes cervical cancer.  The US Centers for Disease Control estimate that 7.4 million American men and women are infected with Trichomonas annually, making it more prevalent than Chlamydia and gonorrhea combined.

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.

Gen-Probe's APTIMA Trichomonas vaginalis assay has been CE marked for sale in the European Union, but has not been cleared for marketing in the United States.