Intelligent Medical Devices (IMDx), a developer of molecular diagnostic products, has received CE mark approval for its automated assay for the detection of C difficile, including the A-B+ 1470 variant, as well as the NAP1 strain.

Under a multi-year distribution agreement with Abbott, IMDx will design, develop, regulatory clear, and manufacture assays for the Abbott FDA cleared m2000 instrument.

The assay for the Abbott m2000 uses IMDx’s proprietary bioinformatics process to demonstrate a sensitivity of 95.7% and a specificity of 100% (internal comparison data).

IMDx chairman and CEO Alice Jacobs said not only do they offer automated detection of toxigenic C difficile genes, shortening the time needed to diagnose infections, but they also cover the detection of hypervirulent strains, including NAP1, and tcdB-variant strains, including 1470.