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Cepheid Molecular Diagnostic Test for MRSA and S. aureus Categorized 'Moderate Complexity' by FDA

SUNNYVALE, Calif., Oct. 15 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced the U.S. Food & Drug Administration (FDA) categorized Cepheid's Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in SSTIs. Xpert MRSA/SA SSTI runs on Cepheid's GeneXpert(R) System, the leading platform for on-demand detection of Healthcare Acquired Infections (HAIs).

Cleared by the FDA for marketing last month, Xpert MRSA/SA SSTI is the first molecular SSTI diagnostic test to receive the moderate complexity CLIA categorization. With this designation, the test is available for use inside and outside of the traditional laboratory setting in approximately 6,000 hospitals throughout the U.S.

"The value proposition of Xpert MRSA/SA SSTI is resonating well with physicians and surgeons -- the healthcare professionals who order tests and prescribe antibiotics as a part of patient treatment plans," said Cepheid Chief Executive Officer John Bishop. "With 'Moderate Complexity' categorization, SSTI test results can be obtained in emergency departments or other near-patient settings in addition to the central laboratory. The key benefit is a potential further reduction in the test time-to-result thereby improving patient management decisions."

MRSA is a bacterium that has become resistant to multiple antibiotics including penicillin and cephalosporins. Current culture-based lab testing methods require 24 - 72 hours to determine if a skin or soft tissue infection is caused by MRSA or SA. As a result, physicians and surgeons often prescribe broad-spectrum, but often suboptimal, antimicrobial therapies while awaiting specific culture and susceptibility results.

In less than one hour, Cepheid's Xpert MRSA/SA SSTI test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with MRSA or SA, giving physicians and surgeons a powerful new tool to aid in quickly selecting the most effective antibiotic therapy to improve patient management.

About the GeneXpert(R) System Molecular Diagnostic Platform

The GeneXpert(R) 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

Based in Sunnyvale, Calif., Cepheid (Nasdaq: CPHD) 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 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 market opportunities and market size. 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; regulatory developments and practices; customer and 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 2007 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.


For Media Inquiries:

Jared Tipton

Cepheid Corporate Communications


For Cepheid Investor Inquiries:

Jacquie Ross

Cepheid Investor Relations


SOURCE Cepheid
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