Cepheid Announces European Release of Improved Test for BCR-ABL Chromosomal Translocation...

Wed Jun 17, 2009 7:00am EDT
 
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Cepheid Announces European Release of Improved Test for BCR-ABL Chromosomal
Translocation Associated With Chronic Myelogenous Leukemia (CML)

 


Oncology Test Further Highlights Broad Market Applicability of GeneXpert
System

SUNNYVALE, Calif., June 17 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD)
today announced the release of its improved Xpert(R) BCR-ABL Monitor test to
be marketed as a CE IVD product under the European Directive on In Vitro
Diagnostic Medical Devices. With improved time-to-results, the test now
detects the BCR-ABL chromosomal translocation in about 2 hours as compared to
2.5 hours for the original product release. The test is intended to aid
European clinicians in the monitoring of patients with Chronic Myelogenous
Leukemia (CML). The test runs on Cepheid's GeneXpert(R) System, the world's
leading on-demand molecular diagnostic platform.

"The GeneXpert System is capable of producing unheard of sensitivity levels
for a molecular system - a potential key benefit in monitoring minimal
residual disease," said John Bishop, Cepheid's Chief Executive Officer.
"Similar to our recently announced test for Mycobacterium tuberculosis, Xpert
BCR-ABL Monitor uses nested PCR, a critical amplification process possible
only within a fully closed integrated molecular sample prep/test system. We
will continue to extend the many unique benefits of the GeneXpert System
across multiple markets and testing applications."

Worldwide, CML affects 1 to 2 people per 100,000 annually.(1) The Europe
Against Cancer Program practice guidelines, for management of patients with
CML, call for use of quantitative Reverse Transcription Polymerase Chain
Reaction (RT-PCR) assays during the initial workup of patients with chronic
phase CML, and in monitoring for minimal residual disease. Patients may have
their blood tested as often as four times a year.
 
"Cepheid's Xpert BCR-ABL Monitor test is a powerful tool for monitoring
patients being treated for Chronic Myelogenous Leukemia," said Dr. Ellie
Nacheva, MD PhD FRCPath, Head of Lab - Leukemia Cytogenetics, Royal Free and
University College School of Medicine. "The unsurpassed sensitivity of the
GeneXpert System enables clinicians to process molecular tests in their own
facilities instead of sending patient samples to a central lab and waiting for
results. A patient's local clinician can now monitor minimal disease levels
very quickly - the key to appropriately managing patients who may be at risk
for relapse."
 
The improved Xpert BCR-ABL Monitor test highlights the broad market
applicability of Cepheid's GeneXpert System. A unique molecular diagnostic
platform, the system has a menu of current and expected tests that span the
Healthcare Associated Infection, Oncology, Women's Health, Critical Infectious
Disease, Immuno-Compromised, and Genetics markets. With an installed clinical
base of over 1,000 GeneXpert Systems worldwide, the platform offers the
potential to standardize molecular-based testing in laboratories and
healthcare institutions.

About Cepheid
Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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.

References
1. Central European Leukemia Study Group 2007. About CML;
http://www.cml-info.com/de/healthcare-professionals/about-cml.html


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, future products 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; unexpected delays in the development
process; uncertainties related to regulatory approval of new products;
unexpected issues arising from clinical trials of proposed products;
regulatory developments and changing practices regarding testing; customer and
market acceptance of products; pricing of new products; 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 products; the
potential need to acquire or license intellectual property for new products;
and the uncertain impact of the global economic downturn. Readers should also
refer to the section entitled "Risk Factors" in Cepheid's Annual Report on
Form 10-K for 2008, 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           investor.relations@cepheid.com






SOURCE  Cepheid

Media, Jared Tipton of Cepheid Corporate Communications, +1-408-400-8377,
jared.tipton@cepheid.com; or Investors, Jacquie Ross of Cepheid Investor
Relations, +1-408-400-8329, investor.relations@cepheid.com

 

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