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Roche MRSA/SA Assay Gains 510(k) Clearance

NEW YORK (GenomeWeb) – Roche today said that the US Food and Drug Administration cleared the cobas MRSA/SA test for the early, simultaneous detection of methicillin-resistant Staphylococcus aureus and methicillin-sensitive Staphylococcus aureus directly from nasal specimens. 

The PCR-based assay detects both bacteria directly from a single specimen and is for use on the automated cobas 4800 system, Roche said, adding that the approach requires less hands-on time and helps laboratories to reduce costs and improve turnaround time. 

"The cobas MRSA/SA test demonstrated excellent performance in detecting both MRSA and SA strains in samples collected throughout theUS," Lance Peterson, director of microbiology and infectious diseases research at North Shore University Health System, said in a statement. He is also a clinical professor of pathology and medicine at theUniversity of Chicago, Pritzker School of Medicine. "Compared to culture testing, the cobas MRSA/SA test offers confidence in identifying colonized patients the first time they are evaluated, aiding in the prevention of MRSA disease and post-operative SA surgical infections," he added.