Healthcare Industry News: Cepheid
News Release - October 26, 2006
Cepheid Extends European Product Line With Launch of Xpert(TM) MRSA Test for GeneXpert(R) SystemWorld's First On Demand Molecular MRSA Test Enables 24/7 Patient Management Capability
SUNNYVALE, Calif., Oct. 26 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced the European release of the Xpert(TM) MRSA (Methicillin-resistant Staphylococcus aureus) test for clinical diagnostic use on the GeneXpert® System. The MRSA test was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices. The Xpert MRSA test is designed to rapidly detect MRSA in patients for surveillance programs to aid in the reduction of hospital acquired infections (HAI).
MRSA is a type of Staphylococcus aureus, which is the most common cause of HAI that resists traditional antibiotic treatment methods requiring specialized antibiotics to effectively treat. The prevalence of MRSA is growing at an alarming rate in Europe. The United Kingdom has one of the highest rates in Europe. According to the BBC, the number of cases of MRSA has been rising sharply from 2,422 in 1997 in England and Wales to 7,684 in 2004 in England alone. A July 2004 report "Improving Patient Care by Reducing the Risk of Hospital Acquired Infection: A Progress Report" published by the House of Commons public accounts committee estimates that each year there are at least 100,000 cases of hospital acquired infection in England causing around 5,000 deaths, and the cost to the National Health Service may be as much as 1 billion Pounds Sterling a year.
"The onus is on health-care authorities to develop not only surveillance systems that are able to monitor the clonal dynamics of MRSA over wide geographical areas but also to provide the resources for early recognition of MRSA carriers through rapid screening," said Professor Hajo Grundmann, MD, Centre for Infectious Diseases Epidemiology, National Institute for Public Health and the Environment, the Netherlands.
"The control of hospital acquired infections (HAI) represents a potential market opportunity of up to $2 billion. A key element to combating the HAI problem is the ability of the hospital to rapidly identify the potential presence of the disease causing organisms twenty four hours a day seven days a week," said Cepheid Chief Executive Officer John Bishop. "The Xpert MRSA test run on our GeneXpert system is uniquely positioned to help provide this 24/7 ability to hospitals and is the first in a series of tests expecting to range from vancomycin resistant enterococcus (VRE) to Clostridium difficile."
Xpert MRSA is intended to detect MRSA directly from a nasal swab specimen and provides results in about seventy-five minutes. The rapid results delivered through use of Xpert MRSA are expected to allow early identification of potential carriers and to allow the proper precautions to be taken to prevent the spread of disease. Patients carrying MRSA must be identified and isolated from the general hospital population as quickly as possible. However, the standard culture screening method is slow (48-72 hrs) and results can be highly variable. During this period, MRSA may be inadvertently spread throughout the hospital. The Xpert MRSA test by providing rapid, on-demand results, should aid in reducing the spread of MRSA.
The GeneXpert® System is currently the only molecular diagnostics platform that integrates microfluidic sample preparation with the sensitivity of real-time polymerase chain reaction (PCR)-based detection resulting in the first easy-to-use system in this rapidly growing field. The GeneXpert® System was released in the Biothreat market in 2004 and has subsequently been proven to be an extremely robust and accurate platform technology with over 1,000 modules and systems in the market generating over 3.5 million anthrax test results in the Biothreat market with no false positives.
Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., is a broad based molecular diagnostics company that develops, manufactures, and markets fully-integrated systems for molecular testing in the clinical, industrial and biothreat markets. Representing a paradigm shift in the automation of molecular diagnostics, the Company's GeneXpert System is the only molecular diagnostic system to combine sample preparation with real time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis in an individual test cartridge. The company is focusing on those applications where 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, potential market size and future products. 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products in the clinical market; the performance and market acceptance of new products; 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 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 2005 and "Risk Factors" 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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