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Cepheid Gets FDA Approval for Trichomonas Test in Men

NEW YORK (GenomeWeb) – Cepheid said yesterday that the US Food and Drug Administration has expanded its approval for Xpert TV, the company's urine-based test for trichomonas, to include its use in symptomatic and asymptomatic men.

Trichomonas is a nonviral sexually transmitted disease caused by infection with the protozoan parasite Trichomonas vaginalis. Xpert TV, which runs on Cepheid's GeneXpert system, received FDA approval for use in women via urine, endocervical swab, or vaginal swab last October. It was cleared for use in men and women in the EU in late 2014.

"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," Cepheid Chief Medical and Technology Officer David Persing said in a statement "Further, there is strong evidence that suggests [the pathogen] acts as a co-factor in sexual transmission of HIV, highlighting the importance of easily accessible diagnostics for all patients, regardless of gender."

Danaher announced yesterday that it plans to acquire Cepheid for $4 billion in cash, or $53 per share. The deal is expected to close by the end of the year.