Cepheid's Xpert(TM) MRSA Test Categorized as 'Moderate Complexity' by FDA

SUNNYVALE, Calif., May 22 /PRNewswire-FirstCall/ -- Cepheid (NASDAQ:CPHD), a multi-national company defining on-demand molecular diagnostics, today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid's Xpert(TM) MRSA test for the rapid detection of Methicillin-Resistant Staphylococcus aureus as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA).

Cleared for marketing by the FDA last month, Xpert MRSA is the first molecular diagnostic MRSA test to receive the moderate complexity CLIA categorization. With this designation, Xpert MRSA is now available for use both within and outside of the traditional laboratory setting of the approximate 4,000 hospitals in the U.S.

"The implementation of MRSA surveillance programs is demonstrating effectiveness in reducing hospital acquired infections (HAI) thereby improving patient welfare and reducing the significant cost associated with HAI. The GeneXpert System is enabling 'on demand testing' and reducing the time from the point at which the patient specimen is taken until the result is returned to the hospital floor to as little as two hours," said Cepheid Chief Executive Officer John Bishop. "With the Moderate Complexity categorization of Xpert MRSA, hospitals will have increased flexibility as to deploying the system for maximum patient benefit and cost benefit."

Cepheid is currently working with a broad range of healthcare organizations in the public and private sector to initiate MRSA surveillance programs. Included in this group are the Veterans Health Administration (VHA) facilities that must comply with a system-wide directive to implement mandatory MRSA surveillance of all patients, implementing molecular diagnostics whenever possible. To date Cepheid has been selected for utilization by ten VA Medical Centers and is under consideration at an additional thirty-seven VA Medical Centers.

"Our goal is to screen all patients entering our hospital to determine their risk of carrying MRSA, and then conduct a swab test on all high risk patients," said Beverly Sturgill, Infection Control Officer for Carilion Roanoke Memorial Hospital in Roanoke, VA. "With Xpert MRSA we are able to get results back within two hours, 24 hours a day, seven days a week. This makes it possible for us to begin contact precautions quickly, improving our ability to prevent transmission."

Running on Cepheid's GeneXpert(R) System, the Xpert MRSA test delivers results in just over one hour, enabling healthcare organizations the ability to rapidly identify MRSA carriers and implement the proper infection control measures to lower hospital acquired infection rates and improve patient care. MRSA is a bacterium that is resistant to antibiotics including methicillin, oxacillin, penicillin and amoxicillin affecting those with weakened immune systems such as hospital patients and nursing home residents.

About the GeneXpert 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 of any clinical environment.

About Cepheid

Cepheid (NASDAQ:CPHD), based in Sunnyvale, Calif., is an on-demand 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 performance and usage in the clinical diagnostics market and future products for the clinical market. 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; uncertainty related to funding levels for government-related programs; uncertainties as to whether any facilities reviewing these programs or products will choose to implement Cepheid's systems, whether due to budgetary constraints, competitive factors, product performance, or otherwise; overall 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 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 forward-looking statement or reasons why results
might differ.

    Ajohn.bishop@cepheid.com                  john.sluis@cepheid.com

    Porter Novelli:                          At Schwartz Communications:
    Jason Spark                              Chris Stamm
    619-849-6005                             415-512-0770
    jspark@pnlifesciences.com                cepheid@schwartz-pr.com

Source: Cepheid

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