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Becton Dickinson Gets FDA OK for Molecular Staph Assay

NEW YORK (GenomeWeb News) – Becton Dickinson today announced that it has received US Food and Drug Administration clearance to market its new assay for detection of Staphylococcus aureus and methicillin-resistant Staphylococcus aureus DNA directly from nasal swabs.

The BD Max StaphSR Assay is for use on the BD Max System, a fully automated molecular diagnostic platform, and can detect mecA dropout mutants and other new strains of MRSA that may not be detected by other assays, said BD.

"Increased accuracy in determining patient colonization with either S. aureus or MRSA can enable clinicians to implement appropriate pre-surgical prophylaxis and direct appropriate utilization of isolation and decolonization," Tobi Karchmer, worldwide VPof medical affairs for BD Diagnostics, said in a statement. "With results available in approximately two hours compared to two or more days for culture methods, the BD MAX StaphSR Assay provides accurate and timely information to help physicians ensure safe and appropriate management of surgical patients."

The BD Max StaphSR Assay joins a portfolio of assays including the BD Max MRSA for MRSA DNA detection and BD Max Cdiff for detection of toxigenic Clostridium difficle DNA, which are already available on the BD Max platform.