SUNNYVALE, Calif., Nov. 24 Cepheid(Nasdaq: CPHD) today announced that Health Canada has issued a medical devicelicense for its Xpert(TM) MRSA/SA Skin and Soft Tissue (SSTI) test for therapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) andStaphylococcus aureus (SA, typically Methicillin-sensitive) in skin and softtissue infections. Availability of the Xpert MRSA/SA SSTI test is expected toempower Canadian physicians and surgeons with a new tool to aid in selectingthe most effective antibiotic therapy to improve patient management.
In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processesspecimens from suspected skin and soft tissue infection swabs to determine ifa patient is infected with MRSA or SA. The new test runs on Cepheid'sGeneXpert(R) System, the world's leading Healthcare Associated Infection (HAI)molecular testing platform.
"The ability to accurately detect MRSA and SA in less than one hour is animportant technological step forward in the management of bothhospital-acquired and community-acquired infections," said Rob Koska,Cepheid's Senior Vice President of Worldwide Commercial Operations. "We arevery pleased to announce the availability of the first rapid molecular SSTIdiagnostic test for MRSA and SA to the Canadian market. With our establishedposition as the leader in HAI testing, we expect Cepheid's GeneXpert System tocontinue to be the molecular platform of choice for the management of HAIs."
MRSA and SA infections are national medical concerns that place millionsof lives at risk and add millions of dollars to healthcare costs each year --both in outpatient, or community-acquired infections, and in-patient, orsurgical site infections acquired within the healthcare environment.According to a new six-year Queens University study, to be published in theDecember 2008 issue of the American Journal of Infection Control, more than250,000 Canadian patients experience infected surgical wounds, bloodinfections, and antibiotic resistant organisms while in the hospital eachyear. The study also states that, since 1999, rates of MRSA have more thandoubled -- from 2 to 5.2 per 1,000 hospital admissions across Canada.
Xpert MRSA/SA SSTI is Cepheid's fifth test to receive a Health CanadaMedical Device License. Xpert(TM) MRSA/SA Blood Culture (BC) and Xpert(TM)HemosIL are currently under review.
About the GeneXpert(R) System Molecular Diagnostic Platform
The GeneXpert(R) 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.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demandmolecular diagnostics company that develops, manufactures, and marketsfully-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 byautomating 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 enablethe analysis of complex biological samples in its proprietary test cartridges.Through its strong molecular biology capabilities, the company is focusing onthose 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; 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 toproduct performance and future market opportunities in Canada. 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 manufacturing problems; regulatory developments and practicesregarding testing; customer and market acceptance of the product; the failureof products to perform as expected, whether due to manufacturing errors,defects or otherwise; the impact of competitive products and pricing;potentially lengthy sales cycles; reimbursement rates for the products; andunderlying market conditions. Readers should also refer to the sectionentitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2007 andin its most recent quarterly report on Form 10-Q, each filed with theSecurities 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: For Cepheid Investor Inquiries: Jared Tipton Jacquie Ross Cepheid Corporate Communications Cepheid Investor Relations 408-400-8377 408-400-8329 firstname.lastname@example.org email@example.com