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Dx Focus: FDA OKs IntelligentMDx C. Difficile Abbott m2000 Assay


IntelligentMDx said today that it has received US Food and Drug Administration clearance for its IMDx C. difficile for Abbott m2000 assay, a test that detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human stool specimens.

IMDx's analytical reactivity studies have demonstrated that its C. difficile assay is capable of detecting 31 different strains representing the global diversity of C. difficile, including NAP1 and tcdB variants.

C. difficile is the leading cause of hospital-acquired diarrhea and is linked to approximately 14,000 deaths in the United States annually, the company said.

IMDx's C. difficile assay is the company's third to receive FDA clearance in the last three months for use on Abbott's fully-automated m2000 system— following the IMDx VanR for Abbott m2000 and IMDx Flu A/B and RSV for Abbott m2000 assays (PCR 9/12/2013)

IMDx has a multi-year distribution agreement with Abbott encompassing a broad real-time PCR test menu designed, developed and manufactured for use on the m2000 system (PCR 3/17/2011).