Advanced MRSA Test Receives US FDA Approval

Clinical laboratories in the United States can now take advantage of a dedicated assay for the rapid diagnosis of MRSA (methicillin-resistant Staphylococus aureus) infections.

The global medical and biotechnological company Becton, Dickinson and Company (Franklin Lakes, NJ, USA) announced that the MAX MRSA XT Assay, which is marketed by their BD Diagnosis subsidiary, had received [US] Food and Drug Administration (FDA) 510(k) approval for use as a diagnostic test.


The MAX MRSA XT Assay is intended for use on the fully automated BD MAX System and complements the MAX StaphSR Assay, which reports results for both Staphylococus aureus (SA) and MRSA.

Both assays employ BD's eXTended Detection Technology to identify a broad range of SA strains including mecA and mecC dropout mutants and new strains of MRSA that may not be detected by other assays.

"Assay design is critical to detect MRSA accurately and ensure appropriate infection control interventions are applied," said Dr. Patrick Murray, worldwide director of scientific affairs at BD Diagnostics. "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."

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