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FDA Clears Gen-Probe's Trichomonas Assay

By a GenomeWeb staff reporter

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has approved Gen-Probe's Aptima Trichomonas vaginalis assay for its automated Tigris platform, the company announced today.

The assay is the first amplified nucleic acid test cleared specifically for Trichomonas vaginalis, the most common curable sexually transmitted infection in the US, where 7.4 million men and women are infected annually, Gen-Probe said, citing statistics from the US Centers for Disease Control and Prevention.

It added that current screening methods for trichomonas — culture methods and "wet mount," where samples are analyzed shortly after collection — are limited by sensitivity and slow turnaround times.

Gen-Probe's assay can be used to test endocervical or vaginal swabs collected by clinicians, urine, and specimens collected in PreservCyt solution from asymptomatic as well as symptomatic women.

"Our assay will provide a convenient tool for physicians an 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," Carl Hull, president and CEO of Gen-Probe, said in a statement.