23 May 2006
 
FIND and CEPHEID to develop rapid TB test for developing nations
GeneXpert® System Uniquely Suited to Bring Sophisticated Molecular Diagnostics to the Third World; Improved Detection Essential in Fighting this Lethal Infectious Disease

Sunnyvale, Calif. & Geneva, Switzerland -- Cepheid (NASDAQ: CPHD), a broad-based molecular diagnostics company, today announced a collaboration with the Foundation for Innovative Diagnostics (FIND), a Geneva-based non-profit organization, to develop a new, rapid molecular diagnostic test for tuberculosis (TB). Funded by the Bill and Melinda Gates Foundation, FIND is dedicated to identifying and applying the latest biotechnology innovations to develop affordable diagnostic tests for diseases affecting underprivileged populations in developing countries. Dr. David Alland, an expert in the field of tuberculosis, and his research group at the University of Medicine and Dentistry of New Jersey will also be collaborating with Cepheid in developing the test to rapidly detect TB mycobacteria in sputum and simultaneously determine whether the organisms are drug resistant. The test will be designed to run on Cepheid’s GeneXpert® System.

There is an urgent need for more accurate and cost-effective diagnostic technologies for diseases of the developing world—particularly TB. A chronic bacterial infection, TB caused an estimated 1.7 million deaths in 2004 according to World Health Organization (WHO) data. The spread of TB has been exacerbated by the large number of global travelers, worldwide rise of multidrug-resistant TB strains, and the global spread of HIV which markedly increases susceptibility to tuberculosis. Immunodeficient HIVpositive patients are particularly vulnerable to TB, which is reported to account for the deaths of 13 percent of patients in this group worldwide.

“Without easy to use diagnostics, too many TB cases go undetected and the disease continues to kill nearly 2 million people a year,” said Dr. Giorgio Roscigno, CEO of FIND. “This collaboration will enable us to harness sophisticated molecular technology to develop an affordable and user-friendly test that can detect TB and its drug-resistant forms.”

Developed a century ago, today’s standard culture method for TB detection takes several weeks to generate results and is frequently inaccurate. Lack of effective diagnostics contributes to the worldwide TB problem, as untreated TB patients remain a source of infection for other members of the community. Current molecular diagnostic detection methods for TB are faster and more accurate than culture, but they are not practical to implement in developing countries which lack the specialized laboratories and highly trained technicians required to run the tests. In addition, these methods do not offer on-demand testing, an important feature for TB control.

“Cepheid is honored to share its technical expertise in molecular diagnostics and its unique testing platform with FIND to develop a solution for this global health problem,” said Cepheid CEO, John Bishop. “Through the ability of the GeneXpert System to uniquely automate the otherwise complicated real-time PCR processes, sophisticated, on-demand molecular diagnostics can be brought to nations where highly trained staff and dedicated facilities are in short supply.”

Mark Perkins, Chief Scientific Officer of FIND, said “today’s standard methods for detecting multidrugresistant TB (MDR TB), which cannot be cured with conventional treatment, require several months to yield results. During this time, patients get sicker or die and pass the infection along to others in the community. This technology can simplify molecular detection of MDR-TB and make early diagnosis possible.”

Representing a paradigm shift in the automation of molecular diagnostics, the GeneXpert System is the only closed, self-contained, fully-integrated and automated system for molecular testing commercially available today. The system will allow healthcare providers to obtain timely, accurate results from virtually any type of raw biological sample, with minimal risk of contamination. The easy to use system is designed to operate in a wide range of environments, including hospitals, public health clinics, physician offices, and industrial settings as applicable.

About FIND
The Foundation for Innovative New Diagnostics (FIND) is a non-profit foundation dedicated to the development and introduction of simple, accurate, reliable and accessible diagnostic tools for poverty related infectious diseases in the developing world. Since its launch at the World Health Assembly in 2003, FIND’s initial focus has been on identifying new tools for the diagnosis of tuberculosis. FIND is also collaborating with the World Health Organization for development and evaluation of new diagnostic tests for human African trypanosomiasis, also known as sleeping sickness, and is planning to introduce into its project profile a program to improve malaria diagnostics. FIND is located in Geneva, Switzerland. For more information, please visit www.finddiagnostics.org.

About Cepheid
Cepheid (Nasdaq: CPHD), based in Sunnyvale, California, is a molecular diagnostics company that develops, manufactures, and markets fully-integrated systems 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 www.cepheid.com for more information.

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 development and product performance. 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: development and manufacturing problems; our ability to successfully obtain regulatory approvals and introduce new products; the performance and market acceptance 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 underlying market conditions worldwide. Readers should also refer to the section entitled "Risk Factors" in Cepheid's Annual Report on Form 10-K for 2005 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 forwardlooking statement or reasons why results might differ.