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FDA clears assay for VRE

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The FDA has cleared a molecular diagnostic test that can detect genes associated with vancomycin-resistant enterococci, according to a company press release.

The IMDx VanR assay (IntelligentMDx) detects vanA and vanB genes, which can be associated with vancomycin-resistant enterococci (VRE). The assay, for use on the m2000 platform (Abbott), can obtain results for up to 46 patients in 3 hours. It can be performed on human perirectal swabs, rectal swabs or stool specimens.