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Cepheid Trichomoniasis Test Gets CE-IVD Mark

NEW YORK (GenomeWeb) – Cepheid said today that the CE-IVD mark has been applied to its Xpert TV molecular test for identifying trichomoniasis, and the test has been launched in Europe.

The CE-IVD Mark enables the Sunnyvale, Calif.-based molecular diagnostics firm to offer the test in markets accepting the CE mark.

The test, which runs on Cepheid's GeneXpert System, is used to detect TV infections in males and females. Trichomoniasis is a nonviral sexually transmitted disease caused by infection with the protozoan parasite Trichomonas vaginalis. The World Health organization has estimated that 160 million cases TV infection are acquired worldwide each year, and only about 30 percent of infected individuals develop any symptoms.

"Xpert TV is the first nucleic acid amplification test to deliver TV results for male urine samples," Cepheid Chairman and CEO John Bishop noted in a statement. "It has been difficult to identify and contain TV infections in men because traditional diagnostic methods are much less sensitive than real-time PCR."

The Xpert Tv test is Cepheid's nineteenth assay to get the CE-IVD mark.

The announcement comes one day after Cepheid said that it had received CE marking for its Xpert Flu/RSV XC, an on-demand molecular test for determination of influenza A and B infection and differentiation of respiratory syncytial virus infection.