Healthcare Industry News:  Cepheid 

Diagnostics FDA

 News Release - March 19, 2007

Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis, Run on the GeneXpert Platform, Receives FDA Clearance

First in Class EV Testing System Can Aid Physicians in Patient Management; GeneXpert(R) Technology Enables On-Demand EV Testing

SUNNYVALE, Calif., March 19 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced it received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) EV test, which runs on the GeneXpert® System, for the presumptive qualitative detection of enterovirus RNA in cerebrospinal fluid (CSF) as an aid in the laboratory diagnosis of enterovirus infection in patients with a clinical suspicion of meningitis. The Xpert EV test, designed to detect enterovirus (EV) RNA in CSF by reverse-transcription real-time polymerase chain reaction (RT-PCR), is the first test of its type to receive FDA clearance.

Enteroviruses cause 85-95 percent of viral meningitis cases, which typically self-resolve in a week to ten days unlike bacterial meningitis, which is potentially fatal. As patients present, the need to provide a tool to aid in the differentiation between the two entities is critical. Current EV testing methods are slow, delivering results in 3-7 days. Cepheid's Xpert EV test in conjunction with standard CSF tests like bacterial Gram stain, bacterial culture, CSF glucose, CSF-blood glucose ratio, CSF protein concentration, and CSF leukocyte count, fills a clinical testing void by making enteroviral results available to physicians in less than 2.5 hours -- 24 hours a day, 365 days a year. With rapid EV results, physicians may be able to make improved patient treatment decisions.

"With Xpert EV, physicians can identify a patient with or without enteroviral meningitis in hours, thereby helping to more quickly begin appropriate treatment," said Harley A. Rotbart, MD, Professor and Vice Chairman of Pediatrics, University of Colorado at Denver and Health Sciences Center's School of Medicine, Denver.

"The ability to get access to molecular test results on a 24/7 basis is one of the keys to helping to improve patient management decisions. The GeneXpert System is unique in its ability to enable this type of testing on a 'round the clock' basis giving the clinician valuable additional information on which they may make their patient management decisions," said Cepheid Chief Executive Officer John Bishop. "This product clearance represents an additional key step in the developing realization of our vision of bringing clinically actionable results to the medical community on a more timely and broadly disseminated basis."

"The Xpert EV test is fast and easy-to-use, enabling community healthcare facilities -- the institutions that see the most EV cases -- to perform rapid, molecular tests around the clock, a service similar to the services offered only by the largest of medical centers," stated Beverly Rogers, M.D., Chief of Pathology at Children's Medical Center Dallas and Professor of Pathology at The University of Texas Southwestern Medical Center at Dallas.

Xpert EV is the first and only RT-PCR test that delivers Enterovirus results in less than two and a half hours compared to up to three days for standard culture testing. Fast, highly specific (96.3%) and sensitive (97.2%), Xpert EV is simple to run, requiring minimal hands on time. This is Cepheid's third clinical in vitro diagnostic test following the FDA 510(k) clearances of the Xpert(TM) GBS and Smart GBS tests for Group B Streptococcus in 2006.

About the GeneXpert 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 reverse transcription and 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 of any clinical environment.

About Cepheid

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 and usage in the clinical diagnostics market and future products for the clinical 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: unforeseen manufacturing problems; customer market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the products; 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.


Source: Cepheid

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