SUNNYVALE, Calif., Nov. 24 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD - News) today announced that Health Canada has issued a medical device license for its Xpert(TM) MRSA/SA Skin and Soft Tissue (SSTI) test for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections. Availability of the Xpert MRSA/SA SSTI test is expected to empower Canadian physicians and surgeons with a new tool to aid in selecting the most effective antibiotic therapy to improve patient management.
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. The new test runs on Cepheid’s GeneXpert® System, the world’s leading Healthcare Associated Infection (HAI) molecular testing platform.
“The ability to accurately detect MRSA and SA in less than one hour is an important technological step forward in the management of both hospital-acquired and community-acquired infections,” said Rob Koska, Cepheid’s Senior Vice President of Worldwide Commercial Operations. “We are very pleased to announce the availability of the first rapid molecular SSTI diagnostic test for MRSA and SA to the Canadian market. With our established position as the leader in HAI testing, we expect Cepheid’s GeneXpert System to continue to be the molecular platform of choice for the management of HAIs.”
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. According to a new six-year Queens University study, to be published in the December 2008 issue of the American Journal of Infection Control, more than 250,000 Canadian patients experience infected surgical wounds, blood infections, and antibiotic resistant organisms while in the hospital each year. The study also states that, since 1999, rates of MRSA have more than doubled -- from 2 to 5.2 per 1,000 hospital admissions across Canada.
Xpert MRSA/SA SSTI is Cepheid’s fifth test to receive a Health Canada Medical Device License. Xpert(TM) MRSA/SA Blood Culture (BC) and Xpert(TM) HemosIL are currently under review.
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.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD - News) 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 in Canada. 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; 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; reimbursement rates for the products; and underlying market conditions. 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 Communications Cepheid Investor Relations 408-400-8377 408-400-8329 jared.tipton@cepheid.com jacquie.ross@cepheid.com
Source: Cepheid
