SUNNYVALE, Calif., Oct. 15 — 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.