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Published on 29 August 2013

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FDA approval and launch

 

 

BD Diagnostics, a segment of BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, has announced the US Food and Drug Administration clearance and launch of the BD ProbeTec™ Trichomonas vaginalis Qx Amplified DNA Assay for the direct qualitative detection of T. vaginalis DNA in endocervical and vaginal samples as well as neat urine specimens to aid in the diagnosis of trichomoniasis on the BD Viper™ System with XTR™ Technology. This assay has been CE-marked to the In Vitro Diagnostic Directive (98/79/EC).
Trichomoniasis is the most common curable sexually transmitted infection (STI). Worldwide, more than 180 million cases are estimated to occur annually.i  Genital inflammation caused by trichomoniasis can increase a woman’s susceptibility to HIV infection. In HIV-infected women, trichomoniasis may increase the likelihood of HIV transmission to sex partners. Furthermore, trichomoniasis is often asymptomatic. For these reasons, experts recommend screening for T. vaginalis in women considered to be at high risk for infection (i.e. women who have new or multiple partners, have a history of STIs, exchange sex for payment, or use injection drugs).
“The global prevalence of trichomoniasis is on the rise and there are more asymptomatic cases than previously thought,” said Chris Demiris, Worldwide Group Marketing Manager, BD Diagnostics – Diagnostic Systems, Women’s Health and Cancer. “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.”
The BD ProbeTec Trichomonas vaginalis Qx Amplified DNA Assay is designed for use with the BD Viper System. Automated DNA extraction and simultaneous amplification and detection maximise laboratory efficiency and quality of results. Compared to wet mount microscopy and culture, the BD ProbeTec Trichomonas vaginalis Qx Assay reduces human intervention and associated variables and improves speed to results. The BD Viper System allows laboratories to test samples in panel mode for T. vaginalis, C. trachomatis and N. gonorrhoea or in batch mode for chlamydia and gonorrhoea, trichomonas and herpes on the same automated platform.


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