IntelligentMDx has secured clearance from the US Food and Drug Administration (FDA) for IMDx VanR for Abbott m2000 assay, an automated molecular diagnostic test that detects the presence of vanA and vanB genes associated with vancomycin-resistant enterococci (VRE).
VRE are bacteria that are resistant to the antibiotic vancomycin, and are responsible for several infections such as those in surgical wound, urinary tract, and bloodstream.
The IMDx VanR for Abbott m2000 assay is meant to be used as an aid to identify, prevent and control vancomycin-resistant colonization in hospital settings.
This is one of the tests in IMDx’s portfolio of infectious disease products that has received clearance from the regulatory agency for use on Abbott’s m2000 completely automated platform.
The automated profile of the IMDx VanR for Abbott m2000 test enables laboratories to obtain results for up to 46 patient samples in just less than three hours, and up to 94 patient samples in less than four hours.
The test is conducted directly on human peri-rectal swabs, rectal swabs, or stool specimens from patients at risk for VRE colonization.
IMDx chairman and CEO Dr Alice Jacobs said that the FDA clearance of the IMDx VanR for Abbott m2000 assay is a step toward the fulfillment of IMDx’s mission to make clinically impactful molecular diagnostic testing solutions available as broadly as possible.
Under a multi-year distribution agreement with Abbott, the IMDx VanR for Abbott m2000 assay is a part of a real-time PCR test menu developed for use on Abbott’s RealTime m2000 system.