IMDx Introduces a CE-Marked Automated Assay for the Detection of C. difficile

Intelligent Medical Devices, Inc. (IMDx) has announced it has received CE-Mark for a high-throughput automated assay for the detection of C. difficile, including the A-B+ 1470 variant, as well as the NAP1 strain. The IMDx™ C. difficile assay for the Abbott m2000™ is the first assay released under a multi-year distribution agreement between Abbott and IMDx whereby IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott FDA cleared m2000 instrument.

Designed utilizing IMDx's proprietary bioinformatics process, the IMDx C. difficile assay for the Abbott m2000 demonstrates a sensitivity of 95.7 percent and a specificity of 100 percent (internal comparison data). C. difficile may develop after prolonged antibiotic use and is the most frequent cause of health-care-associated diarrhea, also causing more severe intestinal conditions such as colitis. The bacterium is easily transmitted via direct contact with high-touch surfaces in patient rooms, contaminated patient-care items, and hands of health-care workers.

'Our assays are developed to incorporate evolving clinical needs. Not only do we offer automated detection of toxigenic C. difficile genes, shortening the time needed to diagnose infections, but we also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470. Early identification of pathogens is critical in improving patient healthcare, shortening hospital stays, and reducing expenses,' says Alice Jacobs, MD, Chairman & CEO of IMDx.