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FDA Clears Cepheid's PCR-based Drug-Resistant S. aureus Test

NEW YORK (GenomeWeb News) — The US Food and Drug Administration has cleared a Cepheid test designed to swiftly detect nosocomial and antibiotic-resistant strain of Staphylococcus, the company said today.
 
Cepheid said its Xpert MRSA test, which operates on the company’s GeneXpert system, identifies methicillin-resistant S. aureus in “just over one hour,” and can be administered 24 hours a day without the need to submit samples to a lab.  
 
Cepheid said MRSA infections are the “leading cause” of nosocomial, or hospital-acquired infections, and that they kill as many as 100,000 patients a year in the US.
 
The company said it is currently “engaged with a broad cross-section of health care organizations” about plans to try using MRSA surveillance systems. These organizations are considering testing only “high risk” cases, or testing “all patient admissions,” the company added.
 
Last month, the FDA cleared the company’s PCR-based Xpert EV meningitis test.

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