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FDA clears MRSA test for marketing
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Medical technology company BD Diagnostics has received FDA clearance to market a molecular assay capable of detecting newly emerging strains of MRSA, according to a company news release.
“Assay design is critical to detect MRSA accurately and ensure appropriate infection control interventions are applied,” Patrick Murray, PhD, worldwide director of scientific affairs at BD Diagnostics, said in the release. “The BD MAX MRSA XT assay helps improve patient safety by providing hospitals with a new solution to detect the latest strains of this drug-resistant superbug.”
According to the company, the assay was designed to identify a range of MRSA strains in colonized patients, including those carrying the mecC gene, which account for nearly 3% of MRSA cases in some settings. It also can distinguish Staphylococcus aureus strains missing the mecA gene, which are sometimes misidentified as MRSA by other commercial assays. False-positive results can lead to unnecessary and expensive treatments for patients.
BD Diagnostics also markets the BD MAX StaphSR assay, which can identify S. aureus and MRSA strains.