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New England Journal of Medicine Study Highlights Need for Rapid, PCR-based Group B Streptococcus (GBS) Testing at Time of Admission for Labor and Delivery

June 24, 2009

SUNNYVALE, Calif., June 24 /PRNewswire-FirstCall/ — Cepheid (Nasdaq: CPHD) today noted that a new article, Evaluation of Universal Antenatal Screening for Group B Streptococcus, published in the June 2009 issue of the New England Journal of Medicine concluded that rapid, PCR-based testing at the time of admission for delivery may improve the accuracy of Group B streptococcal (GBS) screening over the normal antepartum testing done at 35-37 weeks of gestation.

GBS disease is one of the most common infections in the first week following birth and is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from colonized women to their babies during childbirth.

The new article points out that current U.S. Centers for Disease Control (CDC) guidelines for preventing neonatal GBS disease, which call for culture-based screening of expectant mothers at 35-37 weeks of gestation, have helped to reduce incidence of early-onset GBS disease since their implementation in 2002. However, the study also finds that 61.4% of full-term infants born with GBS disease were born to women who had previously screened negative during their 35-37 week gestation.

“This revealing study shows clearly that screening for GBS at 35 to 37 weeks gestation leaves many newborns at significant risk of GBS infection, presumably due to either false negative culture results or due to a change in GBS status, from negative to positive, over time,” said David Persing, MD, PhD, Cepheid’s Executive Vice President, Chief Medical & Technology Officer. “As indicated by the study authors, a more accurate way to identify colonization status and target antimicrobial therapy may be to perform a rapid test at or around the time of delivery.”

Cepheid’s Xpert(R) GBS test is designed to run on a STAT basis, returning positive results in as little as 32 minutes. It is the only in vitro diagnostic test to fully meet current CDC criteria for rapid intrapartum GBS testing. Xpert GBS is also the only PCR-based antepartum and intrapartum GBS test to receive ‘Moderate Complexity’ CLIA categorization by the U.S. Food & Drug Administration (FDA), enabling healthcare professionals such as labor and delivery nurses to run the test near-patient — 24 hours a day, 365 days a year.

Xpert GBS runs on Cepheid’s GeneXpert(R) System, the world’s leading on-demand molecular diagnostic platform.

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 of any clinical environment.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests 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 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: regulatory developments and changing therapeutic practices regarding testing levels and methods; 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 2008 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:
    For Media Inquiries:                 For Cepheid Investor Inquiries:
    --------------------                 -------------------------------
    Jared Tipton                         Jacquie Ross
    Cepheid Corporate Communications     Cepheid Investor Relations
    408-400-8377                         Tel: (408) 400 8329
    jared.tipton@cepheid.com             Investor.relations@cepheid.com

SOURCE Cepheid


Source: newswire



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