SUNNYVALE, Calif. and
GENEVA, Feb. 3, 2011 /PRNewswire/ -- Cepheid (Nasdaq:
CPHD) and FIND (Foundation for Innovative New Diagnostics) today
announced a new collaboration to accelerate the development of a
rapid molecular test for the measurement of human immunodeficiency
virus (HIV) viral load.
The Xpert® HIV viral load test, which will run on Cepheid's
GeneXpert® platform, is expected to complement the ground-breaking
Xpert MTB/RIF test for tuberculosis (TB) and drug-resistance, the
result of a collaboration between Cepheid, FIND and other partners
which was profiled in an article in the New England Journal of
Medicine and endorsed by the World Health Organization in late
2010.
Under the agreement, FIND will also obtain concessionary pricing
in developing countries for Cepheid's sexually transmitted diseases
(STD) test for Chlamydia and Gonorrhea, currently under
development. The resulting program is expected to deliver the
benefits of rapid and accurate molecular testing for TB, HIV and
STDs using a single instrument in some of the most challenging
geographies across the globe.
"Given the particular challenges presented by HIV and TB
co-infection, we believe that the Xpert HIV viral load test will be
an excellent complement to Xpert MTB/RIF, dramatically improving
endemic countries' capacity to diagnose and manage these
infections," said Dr Giorgio
Roscigno, Chief Executive Officer of FIND. "This new
collaboration confirms the possibility of creating diagnostic
platforms for several diseases, thus extending the reach of scarce
resources intended to combat them."
"The GeneXpert System is unique in its ability to deliver the
clinical benefits of molecular testing for virtually any infectious
disease in almost any setting, and Cepheid is proud to continue its
contribution to the global effort against TB and extend that
contribution into HIV," said John
Bishop, Cepheid's Chief Executive Officer. "As a
result of the broad applicability of the GeneXpert System,
investments being made available today in the fight against TB can
be leveraged to the maximum benefit of high burden developing
countries, since they will be able to use the same system for the
detection and management of many different types of disease."
Worldwide, TB is the leading cause of death among people living
with HIV which is the most potent risk factor for the development
of tuberculosis. HIV prevalence among TB patients has been
estimated to be as high as 80%-90% in some areas of sub-Saharan
Africa [1]. In 2004, the WHO recommended increasing collaboration
between HIV and TB programs [2]. However, the WHO estimated in 2010
that only about 5% of people living with HIV were screened for TB
[3]. One of the big hurdles to the effective co-management of HIV
and TB is the lack of combined services, and patients are often
sent back and forth between TB and HIV centers. An HIV viral load
test which can be used on the same machine as the WHO-recommended
Xpert MTB/RIF test would have the potential to revolutionize the
way the two diseases are managed, and perhaps act as a catalyst to
ensure a much more holistic approach to TB/HIV co-infections.
Under the terms of the collaboration, FIND will fund
$5 million in development costs for
the Xpert HIV test. The investment is spread across the life
of the project, with the first payment in the first quarter of
2011, and the last payment expected in the first quarter of 2013.
When commercially available, FIND will gain rights allowing
Cepheid's Xpert HIV viral load test and the Xpert Chlamydia and
Gonorrhea test to be sold at reduced prices to the public and
not-for-profit sector in many countries, delivering the benefits of
rapid and accurate molecular testing to high burden developing
countries around the world.
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 access the full power of molecular
diagnostics. The company's systems enable rapid, sophisticated
genetic testing for organisms and genetic-based diseases by
automating otherwise complex manual laboratory procedures. 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 www.cepheid.com.
About FIND
FIND is dedicated solely to developing affordable, easy-to-use
and cutting edge diagnostic tests that save lives in the poorest
areas of the world. From the initial idea and discovery stage to
putting new tests into practice, the organization works with
multiple and diverse groups, from academia, industry, donors,
partners in the field, Ministries of Health and the World Health
Organization. With five new diagnostic tools for TB already in use,
FIND also has programs in malaria and sleeping sickness. Launched
in 2003, the not-for-profit Foundation, with an established
ISO-certified project management framework, has headquarters in
Geneva and offices in Kampala, Uganda, and New Delhi, India.
FIND is financed by both the private and public sectors. Donors
currently include the Bill & Melinda Gates Foundation,
Government of the Netherlands, the
European Union, UNITAID, UK Department for International
Development, National Institutes of Health (USA) and others. For more information,
visit www.finddiagnostics.org.
Forward-Looking Statements
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, timing of future
product releases and future collaborations. 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: risks relating to the development
process for new products, including unforeseen delays and costs;
the ability to complete clinical trials successfully in a timely
manner; uncertainties related to the regulatory processes; the
performance and market acceptance of any new product; sufficient
customer demand; the occurrence of unforeseen expenditures,
acquisitions or other transactions; the impact of competitive
products and pricing; 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 2009 and 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
- CDC. Provider-initiated HIV testing and counseling of TB
patients---Livingstone District, Zambia, September 2004--December
2006. MMWR 2008;57:285-9.
- World Health Organization. Interim policy on collaborative
TB/HIV activities. Geneva,
Switzerland: World Health Organization; 2004. Available at
http://whqlibdoc.who.int/hq/2004/who_htm_tb_2004.330_eng.pdf.
- World Health Organization. TB/HIV Facts 2010. Geneva, Switzerland: World Health
Organization; 2010. Available at
http://www.who.int/tb/challenges/hiv/factsheet_hivtb_2010.pdf.
CONTACTS:
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For Cepheid Media
Inquiries:
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For Cepheid Investor
Inquiries:
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For FIND:
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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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Krisztina Bagamery
Scientific Communications
Officer
+41 22 749 29 41
krisztina.bagamery@finddiagnostics.org
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SOURCE Cepheid