Healthcare Industry News:  GeneXpert 

Diagnostics Regulatory

 News Release - March 22, 2007

Cepheid Introduces CE Mark Certified Smart HBV(TM) Test for SmartCycler(R) System

Rapid Molecular Test for Hepatitis B Virus Provides Quantitative Assessment of Viral Loads for Improved Patient Treatment

SUNNYVALE, Calif., March 22 (HSMN NewsFeed) -- Cepheid (Nasdaq: CPHD ), a broad-based molecular diagnostics company, today announced the European release of the Smart HBV(TM) (Hepatitis B Virus) Assay for clinical diagnostic use on the SmartCycler® System. The HBV assay was released as a CE IVD Mark product under the European Directive on In Vitro Diagnostic Medical Devices (Annex II, List A), the most rigorous EU requirement, and is intended for the rapid identification of HBV viral load.

HBV is a virus that attacks the liver. According to the World Health Organization, of the two billion people infected with the virus, more than 350 million will have chronic, lifelong infections. These chronically infected patients are at high risk of death from cirrhosis or scarring of the liver and liver cancer. These diseases kill roughly one million people each year.

"The Smart HBV(TM) test developed and produced at our Cepheid AB facility in Stockholm extends and complements our existing line of products for monitoring of viral load in the management of transplant patients," said Cepheid Chief Executive Officer John Bishop. "In addition, we believe the test will be an accurate indicator of responses to antiviral therapy in patients being treated for chronic hepatitis B, and its genotype independence ensures that it can be used in all parts of the world in which HBV is endemic. Cepheid plans to continue to expand our test menu on the SmartCycler system and to adapt these tests, as appropriate, to our fully integrated GeneXpert® system."

The presence of HBV surface antigen (HBsAG), is commonly used to diagnose and monitor acute or chronic HBV infection. HBV DNA levels that persist longer than eight weeks have been shown to indicate a progression to chronic liver disease while clearance of HBV DNA within two weeks of onset of symptoms is associated with complete recovery from acute hepatitis. Persistent clearance of HBV viral DNA after therapy with antiviral drugs is considered to be an indication of therapeutic efficacy.

"It has now been clearly demonstrated that there exists a statistical correlation during chronic hepatitis B between the serum or plasma viral load and extent of liver damage. The monitoring of HBV viremia allows a direct evaluation of the chosen treatment effectiveness," said Dr. Jean-Marie Seigneurin, Professor of Virology, Faculty of Medicine, University of Grenoble, France. "Only the regular monitoring of HBV DNA during treatment allows the rapid detection of the resumption of viral multiplication before it continues to a cytolytic peak. Measurement of the viral DNA by real-time PCR clearly improves the monitoring of HBV by offering better sensitivity, a wider linear range and a better precision."

The SmartCycler System is a leading real-time PCR testing platform for hospitals, university labs and government agencies. By automating the amplification and detection process, the SmartCycler System can deliver highly accurate and consistent test results from prepared biological samples in 30-40 minutes. With up to 96 independently programmable reaction sites, the SmartCycler can simultaneously run multiple tests with different protocols and at different times. This eliminates complex advanced scheduling on larger, more costly systems as well as the need to transport samples to central facilities for analysis.

About Cepheid

Cepheid (Nasdaq: CPHD ), based in Sunnyvale, Calif., 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 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 performance and future product introductions. 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: unforeseen manufacturing problems; customer market acceptance of the product; the failure of products to perform as expected, whether due to manufacturing errors, defects or otherwise; the impact of competitive products and pricing; potentially lengthy sales cycles in some markets; reimbursement rates for the 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 2006 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

Issuer of this News Release is solely responsible for its content.
Please address inquiries directly to the issuing company.

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