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Sep 29, 2008

Cepheid Gets FDA Nod for MRSA and SA Molecular Diagnostic

  • Cepheid obtained FDA clearance for its Xpert™ MRSA/SA Skin and Soft Tissue Infection (SSTI) test. It runs on the GeneXpert® System and in less than an hour, it can process specimens from suspected skin and soft tissue infection swabs, according to the company.

    GeneXpert MRSA SSTI is being made available for purchase immediately. The product has also been in use for research purposes.

    Current culture methods takes two to three days, says John Bishop, CEO. “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,” notes Donna Wolk, research associate, BIO5 Institute at The University of Arizona, who worked with Cepheid on the development of this test. “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.”



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