Cepheid (CPHD) Receives FDA Clearance to Market Xpert CT/NG

December 27, 2012 4:11 PM EST
Cepheid (NASDAQ: CPHD) 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.

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.

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.

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