Healthcare Industry News: Cepheid
News Release - April 17, 2006
Cepheid Submits Xpert(TM) EV Test for United States Regulatory ApprovalAssay for Rapid Detection of Enterovirus-Associated Meningitis Is Second Clinical Submission of Assays for Use on the GeneXpert(R) System
SUNNYVALE, Calif., April 17 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today submitted its Xpert EV(TM) (Enterovirus) Assay for use on the GeneXpert System to the U.S. Food & Drug Administration for regulatory clearance. Cepheid is seeking clearance of this assay as a laboratory test to aid in the detection of EV-associated meningitis.
"The diagnosis of enteroviral infection by RT-PCR testing is a critical component of the management of patients with suspected meningitis, but the test is not widely available outside of medical centers that have sophisticated molecular diagnostics laboratories. Even in medical centers with existing laboratory capacity, the test is not usually available around the clock even though there is significant value in a rapid result," said Cepheid Executive Vice President, Chief Medical and Technology Officer, David H. Persing, M.D., Ph.D.
"The GeneXpert System's combination of automated sample preparation and RT-PCR-based detection is expected to enable clinicians to harness the power of molecular diagnostics twenty four hours a day, seven days a week, without the need for a specialized lab and staff. With the FDA submission of the GeneXpert EV product, Cepheid continues its commitment to expand the number and variety of products in the clinical molecular diagnostics market."
According to the CDC, up to 50,000 people are diagnosed with viral meningitis each year in the United States. Enteroviruses cause 90 percent of viral meningitis cases, and most cases typically self-resolve in a week to ten days. Conversely, bacterial meningitis (caused by a bacterial infection) typically follows a rapid course and is potentially fatal. Every year approximately one-half of a million patients in the United States undergo testing of cerebrospinal fluid, obtained from a lumbar puncture also more commonly referred to as a "spinal tap," to determine the cause of meningitis; culture-based results can take up to three days. Xpert EV is designed to detect EV RNA in cerebrospinal fluid by reverse-transcription real-time polymerase chain reaction (RT-PCR).
The GeneXpert System, a closed, self-contained, fully-integrated and automated system, 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 and deliver answers from unprocessed samples for EV in less than 3 hours, where other testing methods may take upward of three days.
Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market. See www.Cepheid.com for more information.
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 product performance, timing of future product releases, clinical trials and regulatory processes, and the status of the USPS BDS program. 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: uncertainties relating to the FDA regulatory process; unforeseen development and manufacturing problems; our ability to successfully commercialize our stand-alone GeneXpert® system; lengthy sales cycles in certain markets; the performance and market acceptance of new products; sufficient customer demand in the other markets; our reliance on distributors to market, sell and support our products; our success in increasing direct sales; the impact of competitive products and pricing; 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 2005 and its other reports 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.
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