FDA clears Cepheid Xpert CT/NG molecular diagnostic test

Cepheid (NASDAQ: CPHD) today announced that it has received clearance from the U.S. Food & Drug Administration (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.

"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 John Bishop , Cepheid's Chief Executive Officer. "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."

"An on-demand test capable of delivering accurate results while patients are still present in the clinic provides a much-needed advantage in our efforts to control infectious diseases such as chlamydia and gonorrhea.  Delays in treatment can lead to complications in about 1 in 25 infected women awaiting test results," said Dr. Edward Hook , MD, Professor of Medicine and Epidemiology at the University of Alabama, Birmingham, and Director of the STD Control Program for the Jefferson County Department of Health. "In addition, the availability of results in less than 90 minutes is especially important for patients presenting to Emergency Departments and in managing patients who may not return for treatment."

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 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."

Gonorrhea and Chlamydia are Sexually Transmitted Infections (STIs). Both are easily treated when detected and managed quickly. Chlamydia remains the most common sexually transmitted bacterial infection in the United States. While the CDC recommends annual testing for all sexually active women aged 25 and under, their most recent nationally representative estimate among this population found that only 38 percent of sexually active women were tested for chlamydia during the previous year.

Gonorrhea is the second most commonly reported bacterial infectious disease in the country. The CDC estimates that more than 700,000 Americans become infected with gonorrhea every year, yet fewer than half of these infections are diagnosed and reported to the CDC. Current testing protocols for Neisseria gonorrhoeae are often problematic due to cross-reactivity with other organisms, often requiring an additional confirmatory test. These delays and coordination issues can significantly hamper communication and consultation, leaving both patients and their partners uninformed and untreated.

Xpert CT/NG will begin shipping in January.