Cepheid Molecular Diagnostic Test for Positive Blood Culture Bottles Categorized ‘Moderate Complexity’ By FDA
SUNNYVALE, Calif., Nov. 4 /PRNewswire-FirstCall/ — Cepheid today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid’s Xpert(TM) MRSA/SA Blood Culture (BC) test as “Moderate Complexity” under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles.
Cleared by the FDA for marketing last month, Xpert MRSA/SA BC is the first molecular diagnostic test for positive blood culture bottles to receive the moderate complexity CLIA categorization. The test runs on Cepheid’s GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs).
“Cepheid is providing institutions with the most comprehensive product portfolio for rapid detection of MRSA and SA — all of which are now categorized ‘Moderate Complexity’ by the FDA,” said Cepheid Chief Executive Officer John Bishop. “The GeneXpert System is unparalleled in its ability to combine the benefits of molecular testing with on-demand availability. With ‘Moderate Complexity’ categorization, Xpert MRSA/SA BC can now be run 24/7.”
Xpert MRSA/SA BC 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.
Typically, physicians will order a set of blood culture bottles drawn from patients presenting with symptoms of systemic infections. While positive cultures can appear in as little as 6-24 hours, they require further additional 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.
About the GeneXpert(R) System Molecular Diagnostic Platform
The GeneXpert(R) 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.
Based in Sunnyvale, Calif., Cepheid is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems 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: regulatory developments and changing therapeutic practices regarding testing levels and methods; 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; 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.
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