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FDA Clears IMDx C. Difficile Assay for Abbott m2000 System

NEW YORK (GenomeWeb News) – IntelligentMDx today said that the US Food and Drug Administration has cleared its C. difficile assay for the Abbott m2000 system.

The assay, the third to receive FDA clearance for use on Abbott's platform in the past three months, detects nucleic acids encoding the toxin A gene and toxin B gene sequences of toxigenic strains of Clostridium difficile in human liquid or soft stool specimens in patients suspected of having C. difficile-associated illnesses.

Analytical reactivity studies have demonstrated that IMDx's assay detects the 31 different toxigenic C. difficile strains that were tested, the firm said. It added that the strains represent the global diversity of C. difficile strains, including NAP1, as well as tcdB-variant strains, such as 1470.

"FDA clearance of the IMDx C. difficile for Abbott m2000 assay comes at a pivotal time when incidence of C. difficile infection and severity in both hospital and community settings is increasing," Alice Jacobs Nesselrodt, chairman and CEO of IMDx, said in a statement. "Detection of a wide variety of C. difficile strains, including hypervirulent strains, by the IMDx C. difficile for Abbott m2000 assay will help ensure that a high number of cases of C. difficile are detected in a timely manner, regardless of the source of infection."

The assay is part of a menu of PCR-based tests being developed by IMDx under a multiyear deal with Abbott. In September, FDA cleared IMDx's assay for the flu and respiratory virus, and in July, the agency cleared the company's molecular assay for vancomycin-resistant enterococci. Both tests were cleared to run on the m2000 system.

IMDx also said today that it has finished moving its corporate headquarters, manufacturing, and R&D operations into a new space in Waltham, Mass. The new facility features BL-2 laboratory space and GMP manufacturing in compliance with FDA and ISO 13485 standards.