BD’s C. difficile assay receives key regulatory approval

BD has announced that its BD Max Cdiff Assay has been granted regulatory clearance from the US Food and Drug Administration (FDA).

The test is designed for use with the fully-automated BD Max System and can rapidly and accurately detect the toxin B gene in patients suspected of infection of C. difficile, an increasingly prevalent hospital superbug.

Granted CE Mark approval in March 2012, the device's excellent performance in Europe has laid the groundwork for the positive regulatory decision from the FDA and demonstrates the beneficial qualities offered by the assay.

Use of molecular testing has been proven to reduce the number of healthcare facility-associated cases of C. difficile infections.

Tom Polen, president of diagnostic systems at BD Diagnostics, said: "FDA clearance of the BD MAX Cdiff assay gives our customers the ability to balance productivity and cost as they perform laboratory testing for an expanding menu of infectious diseases."

This comes after the firm entered the pharmaceutical industry for the first time last month with the launch of a new line of generic prefilled injectable products in the US.