Cepheid Receives Grant to Develop Sample Processing and Amplification Methods for Detection of Bloodstream Bacteria

SUNNYVALE, Calif., March 20, 2012 /PRNewswire/ -- Cepheid (NASDAQ: CPHD) today announced that, together with the University of Medicine and Dentistry of New Jersey (UMDNJ), it has received a grant from the National Institutes of Health to develop sample processing and amplification methods for highly-sensitive detection of bloodstream bacteria using nested polymerase chain reaction (PCR) on the GeneXpert® System. The $1.3 million grant is for the first year of an expected five-year, $5.5 million program.

While the program is being administered by the National Institute of Allergy and Infectious Diseases (NIAID) through its Partnerships for Biodefense special emphasis program, the company also expects to be able to employ the technology in future clinical products, including planned Xpert® tests for sepsis, ventilator pneumonia, and other critical infectious diseases.

"Cepheid's scientists will focus primarily on sample preparation methods for infectious agents from a wide variety of difficult sample types, especially whole blood — one of the most difficult specimens for sepsis detection," said John Bishop, Cepheid's Chief Executive Officer. "Clinicians want accurate, rapid results directly from a patient specimen without waiting for culture results. This program is expected to contribute to the advancement of products where difficult sample types are present."

Because even an extremely low concentration of bacteria present in a patient's blood can cause life-threatening sepsis, tests to detect blood stream infections (BSI) must be highly sensitive. Most blood stream infections are currently diagnosed by performing a series of blood cultures, a time-consuming process that typically takes days to produce a positive result, and even longer to predict treatment susceptibility.

The overarching goal of the project, scheduled to run through February 2017, is to develop tests to detect a variety of bacterial bioterrorism agents in the case of a terrorist attack. Principal investigator on the grant is Dr. David Alland of UMDNJ, and the work on select agents will be conducted in his laboratories.

"This is very similar to a previous NIAID-funded program conducted on tuberculosis, which supported development of six-color fluorescent detection and reagents-on-board," said David Persing, M.D., Ph.D., Cepheid's Chief Medical and Technology Officer. "We considered that program to be a win-win because some of our tests, in addition to the MTB/RIF test, now employ six-color detection technology. We expect to see similar benefits — both direct and indirect — as a function of this new program, and expect to be able to fully leverage our capabilities in the areas of nested amplification and multiplex PCR pursuant to the next generation of GeneXpert products."

About the GeneXpert® System Molecular Diagnostic Platform

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect, and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands found in clinical environments.

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 perform sophisticated genetic testing for organisms and genetic-based diseases. 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 http://www.cepheid.com.

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 future products, product performance, term and size of the grant program 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: risks relating to the development process for new products and technologies, including unforeseen delays and costs; uncertainties in the government funding process; the ability to complete clinical trials successfully in a timely manner; uncertainties related to the regulatory processes for any new products that may result; the performance and market acceptance of any new product; sufficient customer demand; the impact of competitive products or technologies; 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 2011 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 forward-looking statement or reasons why results might differ.

SOURCE Cepheid

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