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FDA Clears Cepheid's Updated MRSA/SA Test

NEW YORK (GenomeWeb News) – Cepheid today announced that the US Food and Drug Administration has cleared the company's updated Xpert MRSA/SA Blood Culture test running on the GeneXpert system.

The test detects methicillin-resistant Staphylococcus aureus and Staphylococcus aureus in blood culture bottles indicating gram-positive cocci in clusters to determine whether a patient's blood is infected with either bacterium, which are frequent causes of sepsis in hospitalized patients.

Typically, positive results can appear in as little as 16 to 24 hours with culture methods, Cepheid said. Further testing is needed to identify the specific infection-causing organism, though, and while gram stain results can help guide empiric therapy, physicians have often used slower culture methods, which require another 24 to 48 hours for results.

"Having the capability to differentiate MRSA, S. aureus, and [coagulase-negative staphylococci] rapidly in blood culture specimens is a major responsibility of the clinical laboratory," Cepheid VP of Scientific Affairs Fred Tenover said in a statement. "The clear advantage of the three target detection algorithm in the Xpert MRSA/SA BC test is the direct identification of both MRSA and S. aureus in approximately one hour. This is what physicians, microbiologists, and pharmacists need for managing sepsis effectively."

The Xpert MRSA/SA Blood Culture test was updated following a recall by Cepheid in early 2012 of the test when some researchers reported getting inconclusive results. Also, in July 2010, Cepheid similarly voluntarily recalled lots of the test due to reports of false negative results from customers.

FDA originally cleared the assay for marketing in 2008.