SUNNYVALE, Calif., May 23, 2012 /PRNewswire/ -- 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."
Xpert CT/NG will be immediately available as a CE-marked product. Visit www.cepheidinternational.com for Cepheid's complete CE IVD menu of Xpert tests. Xpert CT/NG is expected to become available in the United States in late 2012.
About the GeneXpert® System Molecular Diagnostic Platform
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.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
This press release contains forward-looking statements that are not purely historical regarding Cepheid's or its management's intentions, beliefs, expectations and strategies for the future, including those relating to future products, product performance, and future market opportunities. Because such statements deal with future events, they are subject to various risks and uncertainties, and actual results could differ materially from the company's current expectations. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to: unforeseen delays and costs; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory processes for new products; the performance and market acceptance of any new product; sufficient customer demand; the impact of competitive products or technologies; and underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2011 and in its most recent quarterly report on Form 10-Q, each filed with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differ included in this release are made as of the date of this press release, based on information currently available to Cepheid, and Cepheid assumes no obligation to update any such forward-looking statement or reasons why results might differ.