Cepheid Gets FDA Clearance to Market Xpert MRSA/SA Blood Culture Test
Published: Jun 27, 2013
Cepheid Receives FDA Clearance For Updated Xpert MRSA/SA Blood Culture (BC) Test
SUNNYVALE, Calif., June 27, 2013 /PRNewswire/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert® 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 clusters in about one hour.
Cepheid's updated 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 will enable physicians to manage their patients more effectively, improving patient outcomes.
"In the case of sepsis, one of the ten leading causes of death in the United States, test results must be available on-demand in order to have maximum impact on patient management," said John Bishop, Cepheid's Chairman and CEO. "Our updated Xpert MRSA/SA BC test, along with the GeneXpert System, provides the ability to obtain specific accurate results twenty four hours a day, seven days a week."
Recent CDC data show that S. aureus (including MRSA) is the most common cause of central line-associated bloodstream infections and together with coagulase-negative staphylococci (CoNS) represent almost 24% of all central line infections1. Data on bloodstream infections from Mayo Clinic show that, taken together, S. aureus and CoNS represent almost 28% of significant positive blood cultures2.
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 16-24 hours, but then require further testing to identify the specific organism causing the infection. Although Gram stain results can be helpful for guiding empiric therapy, physicians have traditionally relied on slower culture methods, which often require an additional 24-48 hours.
"Having the capability to differentiate MRSA, S. aureus, and CoNS rapidly in blood culture specimens is a major responsibility of the clinical laboratory. The clear advantage of the three target detection algorithm in the Xpert MRSA/SA BC test is the direct identification of both MRSA and S. aureus in approximately 1 hour," said Fred C. Tenover, Ph.D., Cepheid's Vice President for Scientific Affairs. "This is what physicians, microbiologists, and pharmacists need for managing sepsis effectively."
"I've long been a champion of rapid detection of infections tools like the Xpert MRSA/SA BC test give laboratories the opportunity to expand our roles in healthcare," said Dr. Donna Wolk, Ph.D., System Director, Clinical Microbiology at Geisinger Health Systems and Director of the Infectious Disease Research Laboratory at the Weis Research Center. "We can become diagnostics interventionists, able to catalyze improvements in patient care and healthcare delivery like never before. Plus, the expanded claim that allows the test to be performed from the top three providers of blood culture systems/bottles makes the test applicable to nearly all laboratories, large and small."
Xpert MRSA/SA BC is available for immediate shipment. For more information on this and Cepheid's comprehensive portfolio of Healthcare Associated Infection tests, please visit www.cepheid.com.
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 found in clinical environments.
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company that is dedicated to improving healthcare by developing, manufacturing, and marketing accurate yet easy-to-use molecular systems and tests. By automating highly complex and time-consuming manual procedures, the company's solutions deliver a better way for institutions of any size to perform sophisticated genetic testing for organisms and genetic-based diseases. Through its strong molecular biology capabilities, the company is focusing on those applications where accurate, rapid, and actionable test results are needed most, such as managing infectious diseases and cancer. For more information, visit http://www.cepheid.com.
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 efficacy, the availability and timing of product shipments, and market opportunities. 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: the performance, clinical efficacy and impact on patient outcomes of any new product; uncertainties related to the regulatory processes for new products; supply, development and manufacturing problems, or other unforeseen difficulties in order fulfillment; unknown levels of market acceptance for new products; the level of testing at customer sites; 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 2012 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.
1. Sievert DM et al. Infect Control Hosp Epidemiol. 2013;34(1):1-14
2. Cockerill FR et al. Clin Infect Dis. 1997;24:403-18
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