Updated on 28 December 2012
Good news for patients suffering from sexually transmitted diseases - Cepheid Xpert CTNG test kit gets US FDA nod
Singapore: US FDA approved Xpert CT/NG, a qualitative in vitro molecular diagnostic test for the detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), developed by US-based Cepheid.
"We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG, a test we designed from the ground-up to provide accuracy, ease of use, and results availability," said Mr John Bishop, Cepheid's CEO. "We expect this innovative diagnostic test to deliver new levels of confidence to clinicians, in addition to enabling same-day decisions about treating their patients, the critical first step in effectively managing these epidemics."
Based on Cepheid's unique experience with the biothreat detection program, where more than 11 million tests have been performed, the company has learned that the best way to minimize gonorrhea false positive results is to include more-than-one genetic target.
"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 Mr David Persing, 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," he added.