Cepheid Obtains CE Marking for Same-Day Diagnostic Equipment

Cepheid (Sunnyvale, CA, USA), a molecular diagnostics company that develops and manufactures molecular systems and tests, announced that both Xpert CT/NG and Xpert CT have received CE marking, enabling the products to be shipped to Europe immediately.

The products, which run on Cepheid's GeneXpert System, are in vitro (IV) molecular diagnostic tests that detect and differentiate Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), two sexually transmitted infections (STIs).


Gonorrhoeae and chlamydia are easily treated once diagnosed and managed. However, according to the European Centers for Disease Control and Prevention (ECDC), the rate of infection for both infections has increased during the last decade.

Current testing materials for both gonorrhoeae and chlamydia are slow and problematic, oftentimes requiring additional tests to confirm diagnosis. The delays and inaccuracies in testing have hampered communication between patients and doctors, leaving patients unaware of their infections and unable to procure treatment.

Cepheid’s new products provide diagnostic results in less than 90 minutes, enabling same-day patient consultation and treatment options.

"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, CEO, Cepheid. "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."

Xpert CT/NG will be immediately available as a CE-marked product and is expected to become available in the United States in late 2012.


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