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

SUNNYVALE, Calif. -- Cepheid today announced it has received clearance from the Food and Drug Administration (FDA) to market its Xpert MRSA/SA Skin and Soft Tissue Infection (SSTI) test, which runs on the GeneXpert 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 CEO. "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 healthcare-acquired infections (HAIs) 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. Current culture-based lab testing methods require 48 to 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 antimicrobial therapies while awaiting culture results.

"Millions of patients visit emergency departments and urgent care clinics each year for treatment of 'staph' infections in skin and underlying tissue, many caused by MRSA. Because culture-based antibiotic test results are not available to physicians for several days, physicians have been forced to make decisions about wound drainage and antibiotic therapy without having the benefit of supportive laboratory data," said Dr. Donna Wolk, division chief of clinical microbiology at the College of Medicine; and research associate at the BIO5 Institute at the University of Arizona. "Our clinical trial data show that this new laboratory test makes it possible to accurately detect a staph infection before a patient is released, and it provides information to support treatment choices. In addition, the GeneXpert System supports informed antibiotic choices whereby prescribing antibiotics of last resort can be reserved for those patients truly infected with MRSA, therefore, reducing the chances of microbes further developing antibiotic resistance."

Xpert MRSA/SA SSTI delivers actionable test results to assist physicians and surgeons in selecting accurate treatment plans for improved patient outcomes, better antimicrobial stewardship, and a reduction in both community-acquired and healthcare-acquired infections.

Source: Cepheid