Cepheid, a leading molecular diagnostics company, has received clearance from the US Food and Drug Administration (FDA) to market Xpert TV, a qualitative in vitro diagnostic test for accurate and reproducible identification of trichomoniasis in symptomatic and asymptomatic female patients, using urine, endocervical swab or vaginal swabs collected by the patient in a clinical setting.

Xpert TV becomes the 18th test available to run on Cepheid's GeneXpert System in the US, the world's leading molecular diagnostic platform, and is an important addition to the Xpert women's health portfolio which already includes Xpert CT/NG, Xpert Group B Strep and Xpert HPV (only available outside the US).

Trichomoniasis, the most common nonviral sexually transmitted infection, is caused by the protozoan parasite Trichomonas vaginalis and affects an estimated 170 million people globally every year, including an estimated 3.7 million people each year in the United States. Of those infected, up to 85 per cent of individuals have minimal to no symptoms. TV infection is associated with a two-to-threefold increased risk of HIV acquisition, preterm birth, and other adverse pregnancy outcomes among pregnant women.

"The commercial launch of Xpert TV is particularly timely given the CDC's recently revised recommendation to use highly sensitive and specific NAAT testing for the detection of Trichomonas vaginalis in both symptomatic and asymptomatic patients," said David Persing, M.D., Ph.D, Cepheid's chief medical and technology officer.

"Xpert TV provides reference laboratory levels of performance in an on-demand, easy to use format. For the first time, clinicians can offer same-day consultation and treatment for TV, with results available in about an hour, in most cases."

Xpert TV will begin shipping in the United States in early November.