FDAnews Device Daily Bulletin

BD Plans January Launch of New ‘Superbug’ Diagnostic

Jan. 15, 2014

BD Diagnostics, a unit of Becton, Dickinson and Company, plans to rollout U.S. distribution of a new test for emerging strains of a drug-resistant superbug by the end of the month, following FDA 510(k) clearance this week.

The in vitro BD MAX MRSA XT assay detects the presence of methicillin-resistant staphylococcus aureas in hospital patients, helping to minimize transmission and prevent infections. An earlier version, released in 2013, is also capable of detecting nondrug-resistant SA, but is only indicated for patients about to undergo surgery.

Both assays use the company’s eXTended Detection Technology. MRSA XT relies on a specimen taken using a nasal swab, which is placed in a buffer tube where cells from the swab are released. The tube is then placed on the BD MAX system where lysing of the bacterial cells and extraction and concentration of DNA on magnetic beads is performed automatically. A portion of the DNA is then mixed with polymerase chain reaction reagents with MRSA-specific primers that amplify the genetic target.

The system includes a built-in sample processing control that monitors errors in the process, such as the presence of inhibitory substances, or instrument or reagent errors.

The MRSA XT assay also has CE mark approval. It will be available in the U.S. at the end of January. — Lena Freund

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