CPHD) 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.
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 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.
Cepheid
http://www.cepheid.com
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