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Cepheid Molecular Diagnostic Test for MRSA and S. aureus Categorized 'Moderate Complexity' by FDA
Date:10/15/2008

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.

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3. Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus
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