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HAIs continue to be a national healthcare concern. According to the U.S.Centers for Disease Control and Prevention, in 1974 Methicillin-resistantStaphylococcus aureus (MRSA) infections accounted for two percent of the totalnumber of staph infections. In 1995 that number had grown to 22 percent, andby 2004 that number had further increased to 63 percent.
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"California will be the fifth state to mandate active MRSA surveillanceand testing for patients hospitalized for certain procedures," said JohnBishop, Cepheid's Chief Executive Officer. "This new legislation demonstratesthe need for a portfolio of HAI testing products to address this rapidlygrowing market. As the HAI testing leader, Cepheid is committed to deliveringproducts and services to help healthcare facilities implement effective HAItesting programs."
California SB 1058, signed into law by Governor Schwarzenegger onSeptember 25th, will require hospitals to test certain patients for MRSAwithin the first 24 hours of hospitalization. In addition, hospitals will haveto report, on a quarterly basis, incident rates of HAIs, including MRSA,Vancomyacin-Resistant Enterococci (VRE), and Clostridium difficile (C.difficile).
Cepheid's 2008 and 2009 menu of HAI products includes current and plannedGeneXpert(R) System tests for MRSA surveillance, MRSA skin and soft tissue,MRSA positive blood culture samples, VRE, and C. difficile. These productscontinue to position Cepheid with the most comprehensive HAI testing menuavailable.
HAI Reduction is a Priority at the Federal Level
Dr. Don Wright, the Principal Deputy Assistant Secretary for Health forthe U.S. Health and Human Services Department (HHS) recently reiterated HHS'commitment to reducing HAIs, by discussing his five point strategy to addressthe growing HAI problem.
Starting October 1st, 2008, Centers for Medicare & Medicaid Services (CMS)will no longer pay for the added costs of complications arising from certainhospital-acquired conditions, including catheter associated urinary trackinfections, vascular catheter associated infection, and certain surgical siteinfections (mediastinitis after coronary artery bypass graft, certainorthopedic procedures and certain bariatric surgery for obesity). A portion ofthese infections can be caused by MRSA.
About the GeneXpert System Molecular Diagnostic Platform
The GeneXpert System is a closed, self-contained, fully-integrated andautomated platform that represents a paradigm shift in the automation ofmolecular analysis, producing accurate results in a timely manner with minimalrisk 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 automatednucleic acid analysis. The system is designed to purify, concentrate, detectand identify targeted nucleic acid sequences thereby delivering answersdirectly from unprocessed samples. Modular in design, the GeneXpert System hasa variety of configurations to meet the broad range of testing demands of anyclinical environment.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demandmolecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrialand biothreat markets. The company's systems enable rapid, sophisticatedgenetic testing for organisms and genetic-based diseases by automatingotherwise complex manual laboratory procedures. The company's easy-to-usesystems integrate a number of complicated and time-intensive steps, includingsample preparation, DNA amplification and detection, which enable the analysisof complex biological samples in its proprietary test cartridges. Through itsstrong molecular biology capabilities, the company is focusing on thoseapplications where rapid molecular testing is particularly important, such asidentifying infectious disease and cancer in the clinical market; food,agricultural, and environmental testing in the industrial market; andidentifying bio-terrorism agents in the biothreat market. Seehttp://www.cepheid.com for more information.
This press release contains forward-looking statements that are not purelyhistorical regarding Cepheid's or its management's intentions, beliefs,expectations and strategies for the future, including those relating to futureproducts, product performance and future market opportunities. Because suchstatements deal with future events, they are subject to various risks anduncertainties, and actual results could differ materially from the company'scurrent expectations. Factors that could cause actual results to differmaterially include risks and uncertainties such as those relating to:unforeseen delays in clinical studies or in regulatory approvals; regulatorydevelopments and evolving best practices regarding testing levels; customerand market acceptance of the product; unforeseen manufacturing problems; thefailure of products to perform as expected, whether due to manufacturingerrors, defects or otherwise; the impact of competitive products and pricing;potentially lengthy sales cycles in some markets; reimbursement rates for theproducts; and underlying market conditions worldwide. Readers should alsorefer to the section entitled "Risk Factors" in Cepheid's Annual Report onForm 10-K for 2007 and in its most recent quarterly report on Form 10-Q, eachfiled with the Securities and Exchange Commission.
All forward-looking statements and reasons why results might differincluded in this release are made as of the date of this press release, basedon information currently available to Cepheid, and Cepheid assumes noobligation to update any such forward-looking statement or reasons why resultsmight differ.CONTACTS: For Media Inquiries: Jared Tipton Cepheid Corporate Communications 408-400-8377 [email protected] For Cepheid Investor Inquiries: Jacquie Ross Cepheid Investor Relations Tel: (408) 400 8329 [email protected]
SOURCE Cepheid
