Cepheid and FIND Announce Collaboration to Develop HIV Viral Load Test
By Cepheid, PRNEWednesday, February 2, 2011
Partnership Expected to Expand Molecular Test Offering in Developing Country Markets
SUNNYVALE, California and GENEVA, February 3, 2011 - 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(R) HIV viral load test, which will run on Cepheid's
GeneXpert(R) 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
1) CDC. Provider-initiated HIV testing and counseling of TB patients---Livingstone District, Zambia, September 2004-December 2006. MMWR 2008;57:285-9 (www.cdc.gov/mmwr/preview/mmwrhtml/mm5711a3.htm). 2) World Health Organization. Interim policy on collaborative TB/HIV activities. Geneva, Switzerland: World Health Organization; 2004. Available at whqlibdoc.who.int/hq/2004/who_htm_tb_2004.330_eng.pdf. 3) World Health Organization. TB/HIV Facts 2010. Geneva, Switzerland: World Health Organization; 2010. Available at www.who.int/tb/challenges/hiv/factsheet_hivtb_2010.pdf. CONTACTS: For Cepheid Media Inquiries: For Cepheid Investor Inquiries: Jared Tipton Jacquie Ross Cepheid Corporate Communications Cepheid Investor Relations +1-408-400-8377 +1-408-400-8329 communications@cepheid.com investor.relations@cepheid.com For FIND: Krisztina Bagamery Scientific Communications Officer +41-22-749-29-41 krisztina.bagamery@finddiagnostics.org
Media, Jared Tipton, Cepheid Corporate Communications, +1-408-400-8377, communications at cepheid.com, or Investors, Jacquie Ross, Cepheid Investor Relations, +1-408-400-8329, investor.relations at cepheid.com; or Krisztina Bagamery, Scientific Communications Officer, FIND, +41-22-749-29 41, krisztina.bagamery at finddiagnostics.org
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