Healthcare Industry News: Real-Time PCR
News Release - January 6, 2010
Cepheid Receives FDA Clearance for First Rapid and Accurate Surveillance Test for vanA the Resistance Gene Most Associated with Hospital-Acquired VRE Infections45-Minute Test Further Expands Industry Leading Molecular HAI Test Portfolio
SUNNYVALE, Calif., Jan. 6 (Healthcare Sales & Marketing Network) -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market Xpert® vanA, the first rapid and accurate test released in the United States for vanA, the antimicrobial resistance gene most commonly associated with vancomycin-resistant enterococci (VRE) — one of the more serious healthcare-associated infections (HAI). The 45-minute test runs on Cepheid's GeneXpert® System, the world's leading HAI molecular testing platform.
"As encountered with other HAI-associated pathogens, the lack of a rapid and accurate test for vanA has impacted clinicians' efforts in the recognition, prevention and control of VRE. Xpert vanA should be a significant aid in helping to address this clinical need with fast and accurate test results that can be available on a 24/7 basis," said John Bishop, Cepheid's Chief Executive Officer. "The availability of Xpert vanA adds an additional dimension to the most complete molecular portfolio of test products for management of HAIs on the market today."
The U.S. Centers for Disease Control and Prevention reports that 30 percent of enterococcal HAIs are due to VRE.(1) HAI infections have proven to increase patient length of stays, mortality rates and unnecessary use of antibiotics — leading to dramatically higher costs for healthcare institutions.(2),(3),(4)
Healthcare workers, after contact with asymptomatic colonized patients, may spread VRE to other patients within hospitals. VRE can also be spread directly to people after contacting surfaces that are contaminated with the pathogen.(5)
"Many patients in the areas of oncology, hematology, nephrology, transplant and abdominal surgery units are at highest risk for contracting VRE. Therefore, it's imperative to prevent potential outbreaks by testing for vanA upon admission of high risk patients," said Dr. David Persing, MD, PhD, Chief Medical and Technology Officer at Cepheid. "Several recent studies have demonstrated that a policy of recognition, prevention and control of vancomycin-resistant organisms that colonize patients in healthcare settings can lead to a reduction in transmission rates. A rapid PCR test mitigates perceived drawbacks to preemptive isolation and maximizes medical value by delivering actionable results almost immediately."
Xpert vanA is Cepheid's ninth test to receive FDA clearance, and fifth in its expanding menu of industry-leading HAI products. Xpert vanA will be available for shipment this month. Visit www.cepheid.com for Cepheid's entire line of molecular diagnostic products.
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.
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. 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 fast or as accurately 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 2008 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) National Nosocomial Infection Surveillance System Report, American Journal of Infection Control, 2004
(2) Shadel et al., Infection Control & Hospital Epidemiology 2006; 27:168-1075
(3) Peterson et al., Journal on Quality and Patient Safety 2007; 33: 732-738.
(4) 5 Million Lives Campaign. Institute for Healthcare Improvement. 2007.
(5) Ramadhan and Hegedus, J Clin Pathol 2005; 58:744-746
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