Cepheid, a leading molecular diagnostics company,  has received clearance from the US 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. Xpert CT/NG will begin shipping in January.

"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 gonorrhoea. 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 Programme 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 programme, where more than 11 million tests have been performed, the Company has learned that the best way to minimize gonorrhoea 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 maximise the medical impact of the results."

Gonorrhoea 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 per cent of sexually active women were tested for chlamydia during the previous year.

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.

Cepheid is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests.