Healthcare Industry News: genetic analysis
News Release - October 1, 2008
Cepheid Receives FDA Clearance for First On-Demand Diagnostic Test for Life-Threatening MRSA and Staphylococcus aureus From Patient Positive Blood Cultures
One Hour Test is Cepheid's Second FDA Cleared Diagnostic Test in 2008; Test Improves Time-to-Result by More Than Twenty-Four Hours Over Conventional MethodsSUNNYVALE, Calif., Oct. 1 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Blood Culture (BC) test, which runs on the GeneXpert® System, for the detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically methicillin susceptible) in blood culture bottles showing gram-positive cocci -- in less than one hour.
Cepheid's Xpert MRSA/SA BC test processes positive blood culture specimens to determine if a patient's blood is infected with MRSA or SA, which are frequent causes of sepsis in hospitalized patients. This may enable physicians to quickly de-escalate from broad-spectrum antibiotic treatment to a more effective targeted therapy, thus reducing risk of resistance and improving patient outcomes. If the gram-positive cocci are neither MRSA nor SA, the physician 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 product portfolio for rapid detection of MRSA and SA," said John Bishop, Cepheid's Chief Executive Officer. "The GeneXpert System is unique in its ability to combine the benefits of molecular testing with on-demand availability. In the case 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 of Medicine, the incidence of sepsis is growing at 8.7 percent annually in the U.S., expected to reach more than one million by 2010, while cases of severe sepsis account for up to 11 percent of ICU admissions. The same study states that 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 from patients presenting with symptoms of systemic infections. Positive cultures can appear in as little as 6-24 hours, but then require further testing to identify the specific organism causing the infection. Currently, those additional tests -- most notably to determine if the organism is methicillin-resistant or methicillin-susceptible Staphylococcus aureus -- are done via slower culture testing methods.
"Same day diagnostic results for blood culture bottles growing gram-positive cocci will empower physicians to begin targeted therapy in septic patients far sooner than current culture-based methods," said Dr. Ellen Jo Baron, Director of Clinical Microbiology Laboratories for Stanford University Hospital and Director of Medical Affairs at Cepheid. "These results, delivered 24-48 hours sooner, can potentially improve antibiotic stewardship and provide patients with the best, most effective therapeutic regimen."
According to a Critical Care Medicine study, hospital costs associated with severe sepsis patients are 141 percent higher than those of other patients. 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 in modifying patient treatment plans with targeted therapy to improve patient management, increase antimicrobial stewardship, and control treatment costs associated with the care of sepsis patients.
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 and market size. 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: unforeseen manufacturing problems; regulatory developments and practices regarding testing levels; customer and market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; 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 2007 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.
Source: Cepheid
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