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Cepheid Receives Health Canada Medical Device License For Xpert MRSA(TM) Test And GeneXpert(R) System
Cepheid (Nasdaq:
CPHD) announced that Health Canada has issued a medical device
license for the Xpert(TM) MRSA test for the rapid detection of Methicillin
Resistant Staphylococcus aureus (MRSA) on nasal swabs and the GeneXpert(R)
System. Xpert MRSA test results are available in approximately 70 minutes
thereby enabling rapid identification of carriers of the potential pathogen
in less than two hours, from the acquisition of the patient sample to
returning the result to the floor. The availability of the Xpert MRSA test
and the GeneXpert System is expected to help enable Canadian healthcare
organizations to implement more efficient infection control measures,
leading to lower hospital acquired infection rates and improved patient
care.
As is the situation in the United States, MRSA is a growing public
health concern in Canada. According to a study published in the Canadian
Journal of Infectious Diseases and Medical Microbiology the rate of MRSA in
Canadian hospitals has increased steadily between 1995 and 2004. Patients
with MRSA require prolonged hospitalization extending 26 days on average,
special control measures, expensive treatments and extensive surveillance.
"There is evidence of growing worldwide concern over increasing MRSA
infection rates and other Healthcare Acquired Infections such as
Clostridium difficile. We expect to see more countries moving toward
initiation of active surveillance programs," said Cepheid Chief Executive
Officer John Bishop. "The GeneXpert System is uniquely positioned to enable
organizations to provide fast, reliable MRSA test results 24 hours a day,
seven days a week."
Canadian infection control officers have recommended that hospitals
make prevention of healthcare acquired infections a patient safety
priority, and should commit adequate resources to screening and
implementation of other preventative measures. According to the March 2007
Ontario Provincial Infectious Disease Advisory Committee (PIDAC)
recommendations, high-risk patients, as well as other patients as defined
by local epidemiology and risk factors, should be actively screened for
MRSA.
Xpert MRSA is Cepheid's second test to receive Health Canada license,
following Smart GBS in October of 2007.
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.
About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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 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.
Cepheid
http://www.cepheid.com
Sãnãtate Canada Cepheid primeºte licenþa pentru genul de dispozitiv medical Xpert SAMR (TM) de test ºi de GeneXpert (R) de sistem - Cepheid Receives Health Canada Medical Device License For Xpert MRSA(TM) Test And GeneXpert(R) System - articole medicale engleza - startsanatate