Cepheid Receives FDA Clearance for First On-Demand Diagnostic Test for Life-Threatening MRSA and Staphylococcus aureus From Patient Positive Blood Cultures

Wednesday, October 1, 2008 General News
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SUNNYVALE, Calif., Oct. 1 Cepheid (Nasdaq: CPHD)today announced it has received clearance from the U.S. Food & DrugAdministration (FDA) to market its Xpert(TM) MRSA/SA Blood Culture (BC) test,which runs on the GeneXpert(R) System, for the detection ofMethicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus(SA, typically methicillin susceptible) in blood culture bottles showinggram-positive cocci -- in less than one hour.

Cepheid's Xpert MRSA/SA BC test processes positive blood culture specimensto determine if a patient's blood is infected with MRSA or SA, which arefrequent causes of sepsis in hospitalized patients. This may enable physiciansto quickly de-escalate from broad-spectrum antibiotic treatment to a moreeffective targeted therapy, thus reducing risk of resistance and improvingpatient outcomes. If the gram-positive cocci are neither MRSA nor SA, thephysician may be able to stop antibiotics altogether.

"With the addition of our Xpert MRSA/SA Blood Culture diagnostic test,Cepheid is providing institutions with the most comprehensive productportfolio for rapid detection of MRSA and SA," said John Bishop, Cepheid'sChief Executive Officer. "The GeneXpert System is unique in its ability tocombine the benefits of molecular testing with on-demand availability. In thecase of sepsis, one of the ten leading causes of death in the United States,test results must be available quickly in order to have maximum impact."

According to a 22-year study published in the New England Journal ofMedicine, the incidence of sepsis is growing at 8.7 percent annually in theU.S., expected to reach more than one million by 2010, while cases of severesepsis account for up to 11 percent of ICU admissions. The same study statesthat care of sepsis patients cost hospitals as much as $50,000 per patient,resulting in an annual healthcare burden of $17 billion.

Typically, physicians will order a set of blood culture bottles drawn frompatients presenting with symptoms of systemic infections. Positive culturescan appear in as little as 6-24 hours, but then require further testing toidentify the specific organism causing the infection. Currently, thoseadditional tests -- most notably to determine if the organism ismethicillin-resistant or methicillin-susceptible Staphylococcus aureus -- aredone via slower culture testing methods.

"Same day diagnostic results for blood culture bottles growinggram-positive cocci will empower physicians to begin targeted therapy inseptic patients far sooner than current culture-based methods," said Dr. EllenJo Baron, Director of Clinical Microbiology Laboratories for StanfordUniversity Hospital and Director of Medical Affairs at Cepheid. "Theseresults, delivered 24-48 hours sooner, can potentially improve antibioticstewardship and provide patients with the best, most effective therapeuticregimen."

According to a Critical Care Medicine study, hospital costs associatedwith severe sepsis patients are 141 percent higher than those of otherpatients. The study also found that 72 percent of cases are under-reimbursed,and severe sepsis patients are five times as likely to be outliers.

Xpert MRSA/SA BC delivers on-demand test results to assist physicians inmodifying patient treatment plans with targeted therapy to improve patientmanagement, increase antimicrobial stewardship, and control treatment costsassociated with the care of sepsis patients.

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 combineon-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 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'seasy-to-use systems integrate a number of complicated and time-intensivesteps, including sample preparation, DNA amplification and detection, whichenable the analysis of complex biological samples in its proprietary testcartridges. Through its strong molecular biology capabilities, the company isfocusing on those applications where rapid molecular testing is particularlyimportant, such as identifying infectious disease and cancer in the clinicalmarket; food, agricultural, and environmental testing in the industrialmarket; and identifying 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 Communications Cepheid Investor Relations 408-400-8377 408-400-8329 jared.tipton@cepheid.com jacquie.ross@cepheid.com

SOURCE Cepheid

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