Cepheid’s Xpert CT/NG system receives European CE marking

Cepheid (NASDAQ: CPHD) today announced that both Xpert® CT/NG and Xpert® CT have received CE marking, with shipments expected to begin immediately. Running on Cepheid's GeneXpert® System, the products are qualitative in vitro molecular diagnostic tests for the rapid detection and differentiation of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). With results in less than 90 minutes, new opportunities for same-day patient consultation and treatment are now available.

"We are bringing to market a true next-generation molecular diagnostic product for detection of CT/NG — a test designed from the ground up to provide unprecedented accuracy, ease of use, and results availability," said John Bishop, Cepheid's Chief Executive Officer. "We expect these innovative products to deliver new levels of confidence to clinicians making same-day decisions in consulting with, and treating, their patients — the critical first step in effectively managing these diseases."

"For the first time, we are able to offer highly accurate results we can act upon while the patient is still in the clinic. This may have far-reaching effects, such as improving contact tracing and reducing ongoing spread of infection in the community, as well as being popular with our patients," said Dr. Simon Goldenberg, Consultant Microbiologist, Guy's & St. Thomas' NHS Foundation Trust, London. "I am impressed with the highly accurate results obtained with Xpert CT/NG. The simplicity of sample prep and the easy-to-use format of the GeneXpert cartridge provide same-day results in around 90 minutes."

Gonorrhoeae and Chlamydia are sexually transmitted infections (STIs). Both are easily treated when quickly detected and managed. However, according to the European Centers for Disease Control and Prevention (ECDC), the rate of reported chlamydial infections doubled during the last decade. Complicating the problem are today's slower test methodologies, which make timely patient consultation and treatment a challenge for this reportable disease.

Gonorrhoeae rates are also rising, often as a co-infection with Chlamydia. And 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.

"The Xpert CT/NG test incorporates several novel features — namely, target redundancy for NG and a novel sample adequacy control — that we think will help overcome the limitations of first-generation technologies," 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."