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FDA Clears BD's C. difficile Assay for BD Max System

NEW YORK (GenomeWeb News) – Becton Dickinson's BD Diagnostics segment today said that its BD Max Cdiff Assay has been cleared by the US Food and Drug Administration for marketing in the US.

The assay runs on the BD Max System and detects the toxin B gene, which has been implicated as a cause of disease in patients suspected of having Clostridium difficile. The assay was CE-marked in March 2012.

"The BD Max Cdiff assay is a simple, easy-to-use, fully automated method for detection of these dangerous bacteria," Tom Polen, president of BD Diagnostics – Diagnostic Systems, said in a statement. "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."

Citing statistics from the US Centers for Disease Control and Prevention, BD said that C. difficile kills 14,000 people in the US each year and costs the healthcare system more than $1 billion. The National Action Plan to Prevent Healthcare-Associated Infections aims to reduce C. difficile by 30 percent, the company added.

The BD Max Cdiff assay is the third to be cleared by FDA for the BD Max platform, following the BD Max MRSA test for detecting methicillin-resistant Staphylococcus aureus and the BD Max BGS for detecting Group B Streptococcus.