Healthcare Industry News: Cepheid
News Release - April 18, 2007
Cepheid's Xpert(TM) MRSA Test for Methicillin-Resistant Staphylococcus Aureus Receives FDA ClearanceCross-Section of Healthcare Organizations Ready to Adopt First On-Demand Molecular MRSA Product Designed for 24/7 Active Surveillance Testing
SUNNYVALE, Calif., April 18 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced it received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA test, which runs on the GeneXpert® System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA). Xpert MRSA results, delivered in just over one hour, rapidly identify carriers of the potential pathogen and enable healthcare organizations to implement the proper infection control measures, leading to lower hospital acquired infection rates while improving patient care.
MRSA is a growing public health concern, and is cited as the leading cause of Hospital Acquired Infections (HAI's). According to the U.S. Centers for Disease Control and Prevention (CDC), HAI's number over 2 million annually, and that more than 100,000 hospital patients die each year as a result of contracting an infection while being treated for another condition. According to U.S. Congressional Record (H.R. Bill 1174), these HAI's contribute to over $50 billion in annual medical costs. MRSA infection rates have increased every year since 1970.
Cepheid is currently engaged with a broad cross-section of healthcare organizations interested in initiating MRSA surveillance programs. These institutions are actively planning to initiate programs ranging from testing high-risk patients to testing all patient admissions.
"Currently there are multiple initiatives directed at reducing HAI's, especially those caused by MRSA," said Cepheid Chief Executive Officer John Bishop. "The GeneXpert platform is uniquely positioned to aid hospitals currently doing molecular testing and hospitals considering initiating molecular testing. An additional benefit will be the ability of the GeneXpert system to provide reliable on-demand test information on a 24/7 basis. We expect to see the Xpert MRSA test play a critical role in active surveillance programs nationwide."
The Veterans Health Administration (VHA) is taking a leading role in improving policies to reduce MRSA infection. In January 2007, it issued a directive requiring all VHA facilities to implement MRSA surveillance programs of all patients. While this directive does not mandate polymerase chain reaction (PCR) testing, it advises molecular based testing wherever feasible. Cepheid is currently working with VA hospitals across the country to potentially deploy Xpert MRSA in compliance with this directive.
"Patients that are potential carriers of MRSA are admitted to the hospital at all hours of the day and night," said David H. Persing, MD PhD, Chief Medical and Technology Officer, Cepheid. "But until now, the technology has not existed to provide MRSA STAT testing to enable real-time on-demand patient management decisions and reduce the spread of infection."
MRSA is a bacterium that is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin affecting those with weakened immune systems such as hospital patients and nursing home residents. When MRSA enters the body through the skin it can cause serious skin infections, and if it enters the bloodstream or lungs, it can cause critical blood infections, pneumonia and even death.
About the GeneXpert 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.
Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., is a 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 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 demand and usage in the clinical diagnostics market. 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; customer market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the fact that planned deployments may not result in material amounts of product sales; uncertainties as to whether health care providers that may be considering the product will actually purchase the product in significant quantities; 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 2006 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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