SUNNYVALE, Calif., June 19 /PRNewswire-FirstCall/ -- Cepheid , a broad-based molecular diagnostics company, today announced the European release of the Xpert EV(TM) (enterovirus) Assay for clinical diagnostic use on the GeneXpert(R) System. The EV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The Xpert EV Assay is designed to aid clinicians in the detection of EV-associated meningitis.
Enteroviruses are the most common cause of meningitis, and cause 90 percent of all viral meningitis cases. While viral meningitis typically self-resolves in a week to ten days, bacterial meningitis (caused by a bacterial infection) is potentially fatal. Currently, patients who present with meningitis symptoms must undergo treatment for bacterial meningitis until culture-based test results are available, generally in two to three days.
“Rapid molecular viral diagnosis of a benign disease that does not require treatment, but initially causes concern, is of unquestionable advantage,” said Dr. Helene Peigue-Lafeuille, MD, Ph.D. Professor of Virology and head of the Virology Department at the Hospital of Clermont-Ferrand, France. “The timely availability of additional diagnostic information may be of benefit to both the patient and the community because of its impact on health economics, the needless consumption of drugs and, as a result, resistance to antibiotics. The diagnosis of meningitis can no longer remain a retrospective diagnosis after elimination of all the possible causes since not prescribing unnecessary laboratory tests and not treating are true therapeutic decisions.”
The CE marked Xpert EV(TM) assay is designed to detect EV RNA in cerebrospinal fluid (CSF) by reverse-transcription real-time polymerase chain reaction (RT-PCR). The test can help physicians rule-in viral infection in less than three hours. The rapid results available through use of the Xpert EV assay may assist in determining antibiotic use and hospitalization decisions, and may help reduce the utilization of other more expensive diagnostic modalities such as MRI’s, CT’s and X-rays.
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 Xpert EV assay is the fifth in a planned menu of CE IVD Mark products scheduled to be released in Europe for use on the GeneXpert and SmartCycler(R) Systems during 2006,” said Cepheid Chief Executive Officer John Bishop. “As noted, the GeneXpert System represents a significant paradigm shift in the automation of molecular diagnostics. We expect it to be particularly useful in the clinical market providing application and user benefits with a system flexible enough to meet the diverse needs of the clinical community ranging from hospital and reference labs, to satellite labs and physician’s office labs.”
Cepheid’s GeneXpert(R) Systems are the only systems to combine sample preparation with real time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system purifies, concentrates, detects and identifies targeted nucleic acid sequences, delivering results in under an hour for selected assays and as little as two hours from unprocessed specimens for the Xpert EV assay.
The GeneXpert(R) System is configurable from 4 to 16 modules, allowing users to expand their system as their demand for assays increases. The system boasts full random access capabilities performing multiple diagnostic tests simultaneously. The automated diagnostic software eliminates the need for interpretation by users, which enables the laboratory to be more efficient with more tests.
About Cepheid
Cepheid , based in Sunnyvale, CA., 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 and timing of expansion in the clinical diagnostics market. 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products in the clinical market; the performance and market acceptance of new products; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; 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 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.
CONTACTS: At the Company: John L. Bishop John R. Sluis CEO, Cepheid CFO, Cepheid 408-541-4191 408-541-4191 john.bishop@cepheid.comjohn.sluis@cepheid.com At Financial Relations Board: At Schwartz Communications: Tricia Ross Chris Stamm / Tom Bain Investor/Analyst Information 781-684-0770 617-520-7064 cepheid@schwartz-pr.comtross@financialrelationsboard.com
Cepheid
CONTACT: John L. Bishop, CEO, john.bishop@cepheid.com, or John R. Sluis,CFO, john.sluis@cepheid.com, both of Cepheid, +1-408-541-4191; orInvestor/Analyst Information, Tricia Ross, +1-617-520-7064,tross@financialrelationsboard.com, for Cepheid; or Chris Stamm, or TomBain, both of Schwartz Communications, +1-781-684-0770,cepheid@schwartz-pr.com, for Cepheid
Web site: http://www.cepheid.com//
