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FDA Says Cepheid's MRSA Dx Is Of 'Moderate Complexity'

NEW YORK (GenomeWeb News) — The US Food and Drug Administration has determined that Cepheid’s methicillin-resistant Staphylococcus aureus test is of “moderate complexity” under its Clinical Laboratory Improvement Amendments guidelines, the company said today.
 
Cepheid said that the categorization will enable the Xpert MRSA test to be used both within and outside traditional hospital labs.
 
The FDA in April approved the test, which is designed to rapidly detect MRSA, a common cause of nosocomial infections.
 
The test runs on the company’s GeneXpert system, which combines sample prep with real-time PCR amplification and detection functions, the company said.

The Scan

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