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FDA Clearance for Cepheid's Xpert CT/NG

Cepheid has received clearance from the FDA to market Xpert® CT/NG. Running on Cepheid's GeneXpert® Systems, Xpert CT/NG is a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).For the first time, same-day patient consultation and treatment is possible for the two most common sexually transmitted bacterial infections in the United States.

Xpert CT/NG incorporates several novel design features. First, our research team used in silico approaches to uncover multiple genomic targets for improving the accuracy of both CT and NG detection. Second, we included a first-in-class sample adequacy control that we believe overcomes limitations of first-generation technologies and adds significantly to the interpretation of diagnostic results generated by the GeneXpert System,' said David Persing, MD, Ph.D., Cepheid's Chief Medical and Technology Officer. 'Xpert CT/NG is clearly the most sophisticated test in its class, yet it can be performed on-demand by virtually any laboratory in order to maximize the medical impact of the results.'

 


     
Tags: Chlamydia, Neisseria, FDA, Chlamydia trachomatis

Date Published: January 1, 2013

Source article link: Cepheid » company contact details
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