Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus

Monday, September 29, 2008 General News
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SUNNYVALE, Calif., Sept. 29 Cepheid(Nasdaq: CPHD) today announced it has received clearance from the U.S. Food &Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft TissueInfection (SSTI) test, which runs on the GeneXpert(R) System, for the rapiddetection of Methicillin-resistant Staphylococcus aureus (MRSA) andStaphylococcus aureus (SA, typically Methicillin-sensitive) in skin and softtissue infections.

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, giving physicians and surgeons apowerful new tool to aid in selecting the most effective antibiotic therapy toimprove patient management.

"The ability to detect MRSA or SA in less than one hour, versus two tothree days with current culture methods, will enable clinicians to make real-time decisions as to the best course of treatment or management. The abilityto accurately identify MRSA and SA on a more timely basis is important inmanaging both hospital-acquired and community-acquired infections. Accordingto data from the Centers for Disease Control (CDC), there are approximately 12million patient visits in the U.S. each year for skin infections," said JohnBishop, Cepheid's Chief Executive Officer. "We are very pleased to announcethe first molecular SSTI diagnostic test for MRSA and SA, building on ourestablished position as the leader in the HAI (Healthcare Acquired Infections)testing market. With our expanding test menu, we expect Cepheid's GeneXpertSystem to continue to be the molecular platform of choice for the managementof HAIs."

MRSA is a bacterium that has become resistant to multiple antibioticsincluding penicillin and cephalosporins. Current culture-based lab testingmethods require 48-72 hours to determine if a skin or soft tissue infection iscaused by MRSA or SA. As a result, physicians and surgeons often prescribebroad-spectrum antimicrobial therapies while awaiting culture results.

"Millions of patients visit emergency departments and urgent care clinicseach year for treatment of 'staph' infections in skin and underlying tissue,many caused by MRSA. Because culture-based antibiotic test results are notavailable to physicians for several days, physicians have been forced to makedecisions about wound drainage and antibiotic therapy without having thebenefit of supportive laboratory data," said Dr. Donna Wolk, Division Chief ofClinical Microbiology, College of Medicine; and Research Associate, BIO5Institute at The University of Arizona. "Our clinical trial data show thatthis new laboratory test makes it possible to accurately detect a staphinfection before a patient is released, and it provides information to supporttreatment choices. In addition, the GeneXpert System supports informedantibiotic choices whereby prescribing antibiotics of last resort can bereserved for those patients truly infected with MRSA, therefore, reducing thechances of microbes further developing antibiotic resistance."

Community Acquired Infections in the ER & Healthcare Acquired SurgicalSite Infections

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.

The Centers for Disease Control recently reported that an estimated 12million people in the United States seek outpatient medical attention eachyear for skin and soft tissue infections, of which MRSA plays a major role.Significant incremental healthcare costs associated with these infections area result of additional follow-up visits, changes in antimicrobial therapy, andtransmission of infections to family members and the community.

The Institute of Healthcare Improvement reports that about 800,000surgeries are complicated by infections annually. Cost to the health caresystem to treat these infections is estimated at $9.5 billion, largely due toextended hospital stays following surgery. According to a study published inClinical Infectious Diseases, increased length of stay is 18 days following aMRSA infection and 9 days for a SA infection.

Xpert MRSA/SA SSTI delivers actionable test results to assist physiciansand surgeons in selecting accurate treatment plans for improved patientoutcomes, better antimicrobial stewardship, and a reduction in both community-acquired and healthcare-acquired infections.

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.

About Cepheid

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is an on-demandmolecular diagnostics company that develops, manufactures, and markets fully-integrated systems for genetic analysis in the clinical, industrial andbiothreat markets. The company's systems enable rapid, sophisticated genetictesting for organisms and genetic-based diseases by automating otherwisecomplex manual laboratory procedures. The company's easy-to-use systemsintegrate a number of complicated and time-intensive steps, including samplepreparation, DNA amplification and detection, which enable the analysis ofcomplex 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 toproduct performance and future market opportunities and market size. Becausesuch statements 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 levels; customer and market acceptance of the product; 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: For Cepheid Investor Inquiries: Jared Tipton Jacquie Ross Cepheid Corporate Cepheid Investor Relations Communications 408-400-8329 408-400-8377 jacquie.ross@cepheid.com jared.tipton@cepheid.com

SOURCE Cepheid

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