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Cepheid Receives FDA Clearance for First Rapid On-Demand Molecular Diagnostic Test for MRSA and S. aureus
Date:9/29/2008

Physicians and Surgeons Can Now Diagnose MRSA & SA Soft Tissue Infections

in Less Than One Hour, Leading to More Effective Treatment

SUNNYVALE, Calif., Sept. 29 /PRNewswire-FirstCall/ -- Cepheid (Nasdaq: CPHD) today announced it has received clearance from the U.S. Food & Drug Administration (FDA) to market its Xpert(TM) MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert(R) System, for the rapid detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA, typically Methicillin-sensitive) in skin and soft tissue infections.

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 selecting the most effective antibiotic therapy to improve patient management.

"The ability to detect MRSA or SA in less than one hour, versus two to three days with current culture methods, will enable clinicians to make real- time decisions as to the best course of treatment or management. The ability to accurately identify MRSA and SA on a more timely basis is important in managing both hospital-acquired and community-acquired infections. According to data from the Centers for Disease Control (CDC), there are approximately 12 million patient visits in the U.S. each year for skin infections," said John Bishop, Cepheid's Chief Executive Officer. "We are very pleased to announce the first molecular SSTI diagnostic test for MRSA and SA, building on our established position as the leader in the HAI (Healthcare Acquired Infections) testing market. With our expanding test menu, we expect Cepheid's GeneXpert System to continue to be the molecular platform of choice for the management of HAIs."

MRSA is a bacterium that has become resistant to multiple antibiotics including penicillin and cephalosporins. Curre
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