03 February 2011

Cepheid and FIND announce collaboration to develop HIV viral load test

Partnership expected to expand molecular test offering in developing country markets

Sunnyvale, California and Geneva, Switzerland

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.

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.

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.

References
1. CDC. Provider-initiated HIV testing and counseling of TB patients---Livingstone District, Zambia, September 2004--December 2006. MMWR 2008;57:285-9.
2. 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.
3. 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:

Jared Tipton
Cepheid Corporate Communications
+1 408-400-8377
communications@cepheid.com

Krisztina Bagamery, PhD
FIND Scientific Communications Officer
+41 22 749 29 41
krisztina.bagamery@finddiagnostics.org