Healthcare Industry News: Real-Time PCR
News Release - April 11, 2007
Cepheid's Xpert(TM) EV Test for Enteroviral Meningitis Gains Adoption at Approximately 20 Leading U.S. Medical CentersManaging One of the Largest Enterovirus Testing Populations, Children's Medical Center Dallas Among Leading Institutions to Quickly Adopt Cepheid's On-Demand Xpert EV Test
SUNNYVALE, Calif., April 11 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced that approximately twenty medical centers across the United States have already adopted its Xpert(TM) EV test since it was cleared for marketing by the U.S. Food & Drug Administration (FDA) on March 16, 2007. Xpert EV, which runs on Cepheid's GeneXpert® System, tests 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. Included in the early adaptor group is Children's Medical Center Dallas, one of the largest children's medical centers in the U.S.
"Until now, molecular tests for meningitis were too complex and expensive to be effectively performed in the community healthcare setting," said 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. "Being among the first in the nation to deploy Xpert EV is not simply a great milestone, but it also provides us with a new way to make faster, better informed enterovirus diagnoses for more effective patient treatment. As summer marks the beginning of enterovirus season, the timing is ideal."
Enteroviruses cause 85-95% 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 for a tool to aid in differentiating between the two 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, 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.
"In the weeks Xpert EV has been available, Cepheid has seen demand for the test from some of the nation's top pediatric medical centers," said Cepheid Senior Vice President of Sales and Marketing Robert Koska. "Because the GeneXpert system is fully-integrated and automated, hospitals that once lacked access to molecular diagnostics can now enjoy the full benefits of the technology 24/7, 365 days a year."
Fast, highly specific (96.3%) and sensitive (97.2%), Xpert EV is simple to run, requiring minimal hands on time. It is the first and only molecular test that delivers enterovirus results in less than two and a half hours compared to up to three days for standard culture testing. GeneXpert delivers the benefits of a molecular diagnostic test to institutions that may not have the space or resources to support a full molecular lab.
About Cepheid's GeneXpert System
Cepheid's 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.
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 http://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 product demand. 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; 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; 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 2006 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.
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