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FDA Clears BD's Trichomoniasis Assay for Viper System

NEW YORK (GenomeWeb News) – BD Diagnostics said today that the US Food and Drug Administration has cleared the BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay to run on BD's Viper System with XTR Technology.

The assay is for the qualitative detection of T. vaginalis DNA in endocervical and vaginal samples, as well as neat urine samples, to aid in the diagnosis of trichomoniasis. The assay is also CE-IVD marked.

BD Diagnostics, a segment of Becton Dickinson, today also launched the product.

Running on the BD Viper System, the assay "reduces human intervention and associated variables and improves speed to results," the company said.

"The global prevalence of trichomoniasis is on the rise and there are more asymptomatic cases than previously thought," Chris Demiris, worldwide group marketing manager, BD Diagnostics – Diagnostic Systems, Women's Health and Cancer, said in a statement. "The availability of an automated platform is especially important as clinical and public health communities embrace the need for a test that provides timely and accurate diagnosis of trichomoniasis when screening high-risk populations."

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