FDA Clears First Nucleic Acid Amplification Test to Detect Common Sexually Transmitted Infection Trichomonas Vaginalis U.S. Food and Drug Administration

Gen-Probe Incorporated (NASDAQ: GPRO) announced that the US Food and Drug Administration (FDA) has cleared for marketing its APTIMA® Trichomonas vaginalis assay on the fully automated TIGRIS® system.

The APTIMA assay is the first amplified nucleic acid test specifically cleared to detect Trichomonas vaginalis, the most common curable sexually transmitted infection in the United States. The assay may be used to test clinician-collected endocervical or vaginal swabs, urine, and specimens collected in PreservCyt solution from symptomatic or asymptomatic women.

“We believe our APTIMA Trichomonas assay will improve detection of a potentially serious sexually transmitted infection that is common in women of all ages,” said Carl Hull, Gen-Probe’s president and chief executive officer. “Our assay will provide a convenient tool for physicians and laboratories because it employs the same technology as our market-leading tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system.”

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. The US Centers for Disease Control estimate that 7.4 million American men and women are infected with Trichomonas annually.

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 and is even less sensitive than culture.

 

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