BD Diagnostics obtains FDA approval for BD MAX MRSA XT assay

BD Diagnostics, a segment of Becton, Dickinson and Company (BD), has obtained an approval from the US Food and Drug Administration (FDA) for its BD MAX MRSA XT assay for use on the fully-automated BD MAX system.

BD MAX MRSA XT assay is BD Diagnostics’ second assay capable of detecting newly emerging methicillin-resistant Staphylococus aureus (MRSA) strains with the mecC gene.

BD MAX StaphSR assay was the company’s first assay which was previously launched in 2013 and reported results for both Staphylococus aureus and MRSA. BD Diagnostics claims that this is the first assay in the US to detect mecC strains of MRSA.

Using eXTended detection technology, the BD MAX MRSA XT and BD MAX StaphSR assays identify a broad range of SA strains including mecA and mecC dropout mutants and new strains of MRSA.

BD Diagnostics – Diagnostic Systems Scientific Affairs worldwide director Dr Patrick Murray noted assay design is critical to detect MRSA accurately and ensure appropriate infection control interventions are applied.

"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," Dr Murray added.

The BD MAX MRSA XT assay is BD Diagnostics’ latest milestone demonstrating its commitment to providing advanced assays to detect and prevent healthcare-associated infections (HAI).

The company’s other HAI assays available on the BD MAX System include BD MAX Cdiff and BD MAX StaphSR. BD MAX Cdiff assay detects toxigenic Clostridium difficile DNA.

BD Diagnostics’ BD MAX HAI solutions combine efficiency through system automation with the flexibility to perform multiple HAI assays in the same run, allowing hospital laboratories to customize testing in response to current and future challenges in the fight against HAIs.