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Portland molecular diagnostics laboratory, owned by ICON plc since 2019, that holds the FDA clearance for the MRDx BCR-ABL test in chronic myeloid leukaemia.
MolecularMD Corporation, the applicant at Portland, Oregon on the FDA 510(k) record, holds the clearance for the MRDx BCR-ABL Test (K173492, 22 December 2017), listed by the FDA as the companion diagnostic for nilotinib in chronic myeloid leukaemia. ICON plc announced on 21 February 2019 that it had acquired MolecularMD, which it described as a molecular diagnostic specialty laboratory founded in 2006.
An FDA-cleared blood test that measures the BCR-ABL1 signal of chronic myeloid leukaemia, listed by the FDA as a companion to nilotinib.
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