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Cepheid Receives FDA Clearance for MRSA MDx

NEW YORK (GenomeWeb) – Cepheid announced today that it has received clearance from the US Food and Drug Administration for its Xpert MRSA NxG, a test for methicillin-resistant Staphylococcus aureus (MRSA) infection.

The test runs on the GeneXpert molecular diagnostic system and delivers results in around an hour, the company noted. To develop the test, Cepheid used an extensive library of MRSA strains collected around the world, and it included updated PCR primers and probes that detect both mecA and mecC strains, which reduces the frequency of false-positive results.

"MRSA surveillance remains a critical infection prevention activity for healthcare facilities and one that is challenged by the continued evolution of target sequences within MRSA," Cepheid's Vice President for Scientific Affairs Fred Tenover said in a statement. “Fortunately, our global MRSA surveillance initiative has helped us keep ahead of the curve by alerting us to the emergence of novel strain types, enabling us to design a more comprehensive assay that takes into account major shifts, like the emergence of mecC, as well as more subtle changes in the SCCmec targets."

According to Cepheid, studies have shown that MRSA screening programs using on-demand molecular tests decrease hospital costs, can reduce isolation days of MRSA carriers by 44 percent, and can decrease MRSA infection rates in the ICU by 62 percent.

The newly cleared MRSA test has been validated for use with Copan ESwab and rayon swabs, and it will begin shipping this month, the firm said.