Men in the United States can now have easier access to fast and accurate testing for a potentially dangerous sexually transmitted infection, thanks to expanded claims allowed by the Food and Drug Administration (FDA) for the Xpert TV assay by Cepheid, a sensitive urine-based test for Trichomonas vaginalis that delivers results in as little as 35 minutes.
Trichomoniasis (Trich) is considered to be the most common non-viral sexually transmitted infection in the United States, infecting an estimated 1.4 million men. Trich is particularly challenging because as many as 85% of infected individuals have minimal to no symptoms, allowing for potentially silent spread of the infection.
"A decade ago, Trichomonas vaginalis infections in men were virtually ignored, but recent research has associated these infections with urethritis, prostate inflammation and possibly male infertility," said David Persing, M.D., Ph.D., Cepheid's chief medical and technology officer. "Further, there is strong evidence that suggests Trich acts as a co-factor in sexual transmission of HIV4, highlighting the importance of easily accessible diagnostics for all patients, regardless of gender."
Following initial clearance of Xpert TV for three types of female specimens in October of 2015, the latest clearance extends the range of potential uses of the assay, and positions Xpert TV as the only cleared Nucleic Acid Amplification Testing (NAAT) test for urine samples from symptomatic and asymptomatic men.
Xpert TV extends the reach of Cepheid's portfolio of 20 Xpert tests in the United States for the GeneXpert System, the world's leading molecular diagnostic platform with more than 11,000 systems installed globally. Xpert TV with the extended claim is expected to begin shipping later this month.