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FDA Clears Cepheid's Xpert CT/NG Test

NEW YORK (GenomeWeb News) – The US Food and Drug Administration has cleared Cepheid's Xpert CT/NG test for marketing, the Sunnyvale, Calif.-based company announced after the close of the market on Thursday.

The test for the rapid detection and differentiation of chlamydia and Neisseria gonorrhoeae runs on Cepheid's GeneXpert system and allows for the same-day patient consultation and treatment of the two most common sexually transmitted bacterial infections in the US.

"Xpert CT/NG incorporates several novel design features," David Persing, Cepheid's chief medical and technology officer, said in a statement. "First, our research team used in silico approaches to uncover multiple genomic targets for improving the accuracy of both [chlamydia]and [Neisseria gonorrhoeae] 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. "

Cepheid will begin shipping the test next month, it said. It will compete with Hologic's Gen-Probe, the market leader in the US for CT/NG testing.

"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," Cepheid CEO John Bishop said. "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."

In June, Bishop told investors that the company plans to focus its sales effort for the test on the approximately 2,000 laboratories that already perform molecular testing. He also highlighted the moderate complexity of Xpert CT/NG, compared to the high complexity of competing tests, which will allow Cepheid to market the test to group practice laboratories that can conduct moderately complex tests.

In a research note on Thursday, Ross Muken from the ISI Group said that he anticipates Cepheid will capture about 10 percent of the CT/NG market over an 18- to 24-month period, and is modeling about $15 million of revenue contribution from the test for 2013.

In late-morning trading on the Nasdaq, shares of Cepheid were up about 4 percent to $33.96.