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Cepheid wins FDA clearance to market molecular diagnostic test

Cepheid, a molecular diagnostics company, has received clearance from the FDA to market its Xpert MRSA/SA skin and soft tissue infection test, which runs on the GeneXpert system, for the rapid detection of Methicillin-resistant Staphylococcus aureus and Methicillin-sensitive Staphylococcus aureus in skin and soft tissue infections.

In less than one hour, Xpert MRSA/SA skin and soft tissue infections test processes specimens from suspected skin and soft tissue infection swabs to determine if a patient is infected with Methicillin-resistant Staphylococcus aureus (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 company said.

John Bishop, Cepheid’s CEO, said: “The ability to accurately identify MRSA and SA on a more timely basis is important in managing both hospital-acquired and community-acquired infections. With our expanding test menu, we expect Cepheid’s GeneXpert system to continue to be the molecular platform of choice for the management of healthcare acquired infections.”