September 29, 2008
Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. Aureus
SUNNYVALE, Calif., Sept. 29 /PRNewswire-FirstCall/ -- Cepheid today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert(R) System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections.
In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with MRSA or SA, giving physicians and surgeons a powerful new tool to aid in selecting the most effective antibiotic therapy to improve patient management.
"The ability to detect MRSA or SA in less than one hour, versus two to three days with current culture methods, will enable clinicians to make real- time decisions as to the best course of treatment or management. The ability to accurately identify MRSA and SA on a more timely basis is important in managing both hospital-acquired and community-acquired infections. According to data from the Centers for Disease Control (CDC), there are approximately 12 million patient visits in the U.S. each year for skin infections," said John Bishop, Cepheid's Chief Executive Officer. "We are very pleased to announce the first molecular SSTI diagnostic test for MRSA and SA, building on our established position as the leader in the HAI (Healthcare Acquired Infections) testing market. With our expanding test menu, we expect Cepheid's GeneXpert System to continue to be the molecular platform of choice for the management of HAIs."
MRSA is a bacterium that has become resistant to multiple antibiotics including penicillin and cephalosporins. Current culture-based lab testing methods require 48-72 hours to determine if a skin or soft tissue infection is caused by MRSA or SA. As a result, physicians and surgeons often prescribe broad-spectrum antimicrobial therapies while awaiting culture results.
"Millions of patients visit emergency departments and urgent care clinics each year for treatment of 'staph' infections in skin and underlying tissue, many caused by MRSA. Because culture-based antibiotic test results are not available to physicians for several days, physicians have been forced to make decisions about wound drainage and antibiotic therapy without having the benefit of supportive laboratory data," said Dr. Donna Wolk, Division Chief of Clinical Microbiology, College of Medicine; and Research Associate, BIO5 Institute at The University of Arizona. "Our clinical trial data show that this new laboratory test makes it possible to accurately detect a staph infection before a patient is released, and it provides information to support treatment choices. In addition, the GeneXpert System supports informed antibiotic choices whereby prescribing antibiotics of last resort can be reserved for those patients truly infected with MRSA, therefore, reducing the chances of microbes further developing antibiotic resistance."
Community Acquired Infections in the ER & Healthcare Acquired Surgical Site Infections
MRSA and SA infections are national medical concerns that place millions of lives at risk and add millions of dollars to healthcare costs each year - both in outpatient, or community-acquired infections, and in-patient, or surgical site infections acquired within the healthcare environment.
The Centers for Disease Control recently reported that an estimated 12 million people in the United States seek outpatient medical attention each year for skin and soft tissue infections, of which MRSA plays a major role. Significant incremental healthcare costs associated with these infections are a result of additional follow-up visits, changes in antimicrobial therapy, and transmission of infections to family members and the community.
The Institute of Healthcare Improvement reports that about 800,000 surgeries are complicated by infections annually. Cost to the health care system to treat these infections is estimated at $9.5 billion, largely due to extended hospital stays following surgery. According to a study published in Clinical Infectious Diseases, increased length of stay is 18 days following a MRSA infection and 9 days for a SA infection.
Xpert MRSA/SA SSTI delivers actionable test results to assist physicians and surgeons in selecting accurate treatment plans for improved patient outcomes, better antimicrobial stewardship, and a reduction in both community- acquired and healthcare-acquired infections.
About the GeneXpert(R) System Molecular Diagnostic Platform
The GeneXpert(R) 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 is an on-demand 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 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 and market size. 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 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 2007 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.
CONTACTS: For Media Inquiries: For Cepheid Investor Inquiries: Jared Tipton Jacquie Ross Cepheid Corporate Cepheid Investor Relations Communications 408-400-8329 408-400-8377 [email protected] [email protected]
Web site: http://www.cepheid.com/