SUNNYVALE, California, March 31 /PRNewswire/ --
- World's Most Comprehensive On-Demand HAI Test Portfolio Now Available to European Hospitals
Cepheid (Nasdaq: CPHD) today announced the release of the Xpert(R) MRSA/SA Nasal test as a European CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The test is designed for the simultaneous detection of nasal carriage of both Methicillin-resistant Staphylococcus aureus (MRSA) and Methicillin-sensitive Staphylococcus aureus in less than one hour. Xpert MRSA/SA Nasal is Cepheid's tenth CE IVD test for use on the GeneXpert(R) System, the world's leading Healthcare Associated Infection (HAI) molecular testing platform.
With the addition of Xpert MRSA/SA Nasal, Cepheid now offers European clinicians the most comprehensive suite of on-demand molecular tests currently available to aid in the overall management of HAIs, said John Bishop, Cepheid's Chief Executive Officer. This includes a broad line of diagnostic, surveillance, and pre-surgical screening tests for MRSA, SA, C. difficile, and vanA/vanB.
Staphylococcus aureus is widely recognized as one of the most common causes of HAIs worldwide. Surgical units are high-risk areas for potentially serious consequences of post-operative complications, including surgical site infections (SSIs). Cepheid's on-demand Xpert MRSA/SA Nasal test provides rapid determination of pre-operative carrier status by detecting MRSA and S. aureus, enabling clinicians to determine the best course of treatment for colonized patients.
Determining pre-operative carrier status of S. aureus, including MRSA, can be helpful in targeting patient treatment, including decolonization, shown to reduce post operative SSIs, said Professor Jan Kluytmans, MD, Professor of Medical Microbiology and Infection Control, VUmc, Amsterdam. This is particularly important given the high economic burden of S. aureus infection among patients admitted for elective surgery.
Conventional lab culture techniques require at least 24 hours to identify S. aureus. In contrast, rapid diagnostic tests can yield results at time of the initial preadmission screening visit, so clinicians can better counsel patients if results are positive, and can consider enhanced treatment approaches including decolonization to reduce the risk of post-surgical infectious complications.
Carriers of MRSA and S. aureus are at increased risk of developing post-operative SSIs. Studies have shown up to 80 percent of hospital-acquired S. aureus infections are caused by the patients' own flora, and colonized patients are up to nine times more likely to develop surgical site infections than non-carriers. As of April 1, the UK Department of Health has provided guidance that all NHS trusts must introduce MRSA screening for all elective surgery admissions. They must also extend screening to cover all emergency admissions no later than 2011.
Recent reports note that 29 million surgical procedures are performed each year in Europe and approximately 2.6 percent of these patients develop SSIs while recuperating in European hospitals. Once a patient has developed an SSI, their average length-of-stay is increased by 6.5 days and it costs three times as much to treat an infected person.
Cepheid (Nasdaq: CPHD), based in Sunnyvale, Calif., is a 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 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 changing practices regarding testing; 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 economic conditions . Readers should also refer to the section entitled Risk Factors in Cepheid's Annual Report on Form 10-K for 2008, 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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