Canadian Physicians and Surgeons Can Now Diagnose MRSA and SA Skin and Soft Tissue Infections in Less Than One Hour, Leading to More Effective Treatment

SUNNYVALE, Calif., Nov. 24 — Cepheid (Nasdaq: CPHD – News) today announced that Health Canada has issued a medical device license for its Xpert(TM) MRSA/SA Skin and Soft Tissue (SSTI) test for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections. Availability of the Xpert MRSA/SA SSTI test is expected to empower Canadian physicians and surgeons with a new tool to aid in selecting the most effective antibiotic therapy to improve patient management.

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. The new test runs on Cepheid’s GeneXpert® System, the world’s leading Healthcare Associated Infection (HAI) molecular testing platform.

“The ability to accurately detect MRSA and SA in less than one hour is an important technological step forward in the management of both hospital-acquired and community-acquired infections,” said Rob Koska, Cepheid’s Senior Vice President of Worldwide Commercial Operations. “We are very pleased to announce the availability of the first rapid molecular SSTI diagnostic test for MRSA and SA to the Canadian market. With our established position as the leader in HAI testing, we expect Cepheid’s GeneXpert System to continue to be the molecular platform of choice for the management of HAIs.”

MRSA and SA infections are national medical concerns that place millions of lives at risk and add millions of dollars to healthcare costs each year — both in outpatient, or community-acquired infections, and in-patient, or surgical site infections acquired within the healthcare environment. According to a new six-year Queens University study, to be published in the December 2008 issue of the American Journal of Infection Control, more than 250,000 Canadian patients experience infected surgical wounds, blood infections, and antibiotic resistant organisms while in the hospital each year. The study also states that, since 1999, rates of MRSA have more than doubled — from 2 to 5.2 per 1,000 hospital admissions across Canada.

Xpert MRSA/SA SSTI is Cepheid’s fifth test to receive a Health Canada Medical Device License. Xpert(TM) MRSA/SA Blood Culture (BC) and Xpert(TM) HemosIL are currently under review.

About the GeneXpert® System 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.