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IMDx VanR Assay for Abbott MDx System Cleared in Canada, Singapore

NEW YORK (GenomeWeb News) — IMDx said today that its IMDx VanR assay for the Abbott m2000 platform has received regulatory clearance from Health Canada and Singapore's Health Sciences Authority, allowing the test to be sold and distributed in those countries.

The assay detects the presence of vanA and vanB genes that can be associated with vancomycin-resistant enterococci. It is intended to be used as an aid to identify, prevent, and control vancomycin-resistant colonization in healthcare settings.

The test was previously cleared by the US Food and Drug Administration and has received CE marking.

IMDx also said that it has initiated development of the IMDx EBV for Abbott m2000 assay, a test for the quantitative measurement of Epstein-Barr virus DNA in human whole blood or plasma specimens in order to aid in monitoring viral response to antiviral treatment or immunosuppressive therapy.