SUNNYVALE, Calif., Aug. 9, 2011 /PRNewswire/ -- Cepheid (NASDAQ:
CPHD) today announced the release of an updated Xpert® BCR-ABL
Monitor test, now reporting results to the International Scale. The
test is being released as a European CE IVD Mark product under the
European Directive on In Vitro Diagnostic Medical Devices.
The test, which runs on Cepheid's GeneXpert® System, detects the
BCR-ABL mRNA transcript in the peripheral blood of patients with
Chronic Myelogenous Leukemia (CML) in about two hours.
"Our work in the CML area is the first of several initiatives we
are developing as we extend the GeneXpert System test menu into a
new line of molecular diagnostic oncology products," said
John Bishop, Cepheid's Chief
Executive Officer. "The updated Xpert BCR-ABL Monitor test
incorporates a fully validated test-specific conversion factor
aligned to the International Scale — an important factor in helping
to maintain consistency within and between laboratories to more
accurately monitor patient progression toward remission."
CML is a cancer of the myeloid lineage of leukocytes (white
blood cells) that is characterized by the presence of the
"Philadelphia Chromosome," a reciprocal translocation of
chromosomes 9 and 22 that results in the generation of the BCR-ABL
fusion gene. The BCR-ABL protein functions as a constitutively
activated Tyrosine Kinase that drives the proliferation of immature
myeloid cells.
If untreated, CML progresses within several years from a chronic
phase to accelerated and blastic phases, with survival in the
blastic phase measured in months. The introduction of the targeted
Tyrosine Kinase Inhibitors (TKIs) imatinib, dasatanib and nilotinib
has had a profound impact on the survival of patients with CML.
Since their introduction, CML has been transformed into a chronic
condition with good long-term prognosis. Monitoring the levels of
BCR-ABL mRNA transcript in the blood of CML patients on TKIs using
real-time quantitative PCR has become standard of care in the
management of CML. The goal of treatment is to reach a major
molecular response (MMR), defined as a 3 log reduction (< 0.1%)
in BCR-ABL mRNA levels from a standardized baseline defined by the
International Scale(1,2). In order to accurately assess treatment
response, it is essential that variability in testing methodologies
be tightly controlled. This has resulted in substantial efforts to
standardize BCR-ABL molecular testing across laboratories by
introducing an International Scale(3).
The updated Xpert BCR-ABL Monitor is now available as a CE IVD
Mark product. For more information, visit
www.cepheidinternational.com for Cepheid's complete menu of
CE IVD Xpert tests.
About Cepheid
Based in Sunnyvale, Calif.,
Cepheid (Nasdaq: CPHD) is a leading molecular diagnostics company
that is dedicated to improving healthcare by developing,
manufacturing, and marketing accurate yet easy-to-use molecular
systems and tests. By automating highly complex and time-consuming
manual procedures, the company's solutions deliver a better way for
institutions of any size to perform sophisticated genetic testing
for organisms and genetic-based diseases. Through its strong
molecular biology capabilities, the company is focusing on those
applications where accurate, rapid, and actionable test results are
needed most, such as managing infectious diseases and cancer. For
more information, visit http://www.cepheid.com.
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 planned new product releases, product
performance and future market opportunities. 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;
uncertainties in the regulatory review process for new products;
regulatory developments and practices regarding testing protocols;
customer and market acceptance of our products; the failure of
products to perform as fast or as accurately 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 2010 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.
References
- NCCN Guidelines™ version 2.2011 Chronic Myelogenous
Leukemia
- Baccarani M et.al. Chronic myeloid leukemia: an update of
concepts and management recommendations of European LeukemiaNet. J
Clin Oncol. 2009 Dec 10;27(35):6041-51. Epub 2009 Nov
- Cayuela JM., Cartridge-based automated BCR-ABL1 mRNA
quantification: solving the issues of standardization, at what
cost? Haematologica. 2011 May;96(5):664-71. Epub 2011 Feb 17
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CONTACTS:
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For Media
Inquiries:
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For Cepheid Investor
Inquiries:
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Jared Tipton
Cepheid Corporate
Communications
408-400-8377
communications@cepheid.com
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Jacquie Ross
Cepheid Investor
Relations
408-400-8329
investor.relations@cepheid.com
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SOURCE Cepheid