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Gut infection test gets FDA go-ahead

BD Diagnostics, of Sparks, a segment of Becton, Dickinson & Co., a global medical technology company, announced it has received U.S. Food and Drug Administration clearance to market the BD MAX Cdiff Assay in the United States.

The assay. already in use in Europe, is designed to rapidly and accurately detect the toxin B gene, which has been shown to cause disease in patients suspected of Clostridium difficile infection.

Clostridium difficile is a bacteria that causes a gut infection that causes diarrhea and other serious intestinal conditions, such as colitis, and is a growing threat in hospitals, nursing homes and other health care settings.