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FDA Clears IMDx's MDx for Vancomycin-resistant Enterococci

NEW YORK (GenomeWeb News) – IntelligentMDx today announced it has received clearance from the US Food and Drug Administration for its molecular diagnostic test for vancomycin-resistant enterococci.

IMDx's assay detects the presence of vanA and vanB genes that have been associated with vancomycin-resistant enterococci, which are responsible for healthcare-related infections that include surgical wounds, urinary tract, and bloodstream infections.

The test runs on Abbott's fully automated m2000 platform, and is part of a broad menu of real-time PCR tests developed for use on the instrument under a multiyear distribution agreement that IMDx has with Abbott.

Because IMDX's assay is automated, laboratories are able to obtain results for up to 46 patient samples in less than three hours, and up to 94 samples in less than four hours, the Cambridge, Mass.-based firm said. The assay is performed directly on human peri-rectal swabs, rectal swabs, or stool samples.

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