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BD Diagnostics Gets FDA Clearance for Second BD Max Staph Assay

NEW YORK (GenomeWeb News) — BD Diagnostics, a segment of Becton Dickinson, said today that it has received US Food and Drug Administration clearance to market its BD Max MRSA XT assay for use on the BD Max system.

This is the second assay from BD Diagnostics capable of detecting newly emerging methicillin-resistant Staphylococcus aureus strains with the novel mecC gene. The company's BD Max StaphSR assay for use on the BD Max system received FDA clearance in December.

Both assays use BD's "eXTended" detection technology to identify a broad range of S. aureus strains including mecA and mecC dropout mutants and new strains of MRSA, the company said.

However, the new BD Max MRSA XT provides a single actionable result — positive of negative for MRSA — whereas StaphSR provides two actionable results — positive or negative for S. aureus and for MRSA, according to a spokesperson.

In addition, the spokesperson said that BD Max MRSA ST is intended for use in active surveillance programs to help hospitals accurately identify patients colonized with MRSA, while StaphSR is intended to be used in pre-surgical screening to identify patients colonized with S. aureus or MRSA.

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