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Health Canada Approves Two BCR-ABL Tests

NEW YORK (GenomeWeb) — Asuragen and MolecularMD announced today that Canadian regulators have approved their BCR-ABL tests for use in chronic myeloid leukemia (CML) patients.

According to Austin, Texas-based Asuragen, Health Canada has approved its qPCR-based QuantideX BCR-ABL IS kit. The test is designed to detect and quantify major breakpoint BCR-ABL1 fusion transcripts and is used to monitor molecular response in CML patients, regardless of tyrosine kinase inhibitor (TKI) therapy or disease management approach. The kit received US Food and Drug Administration premarket clearance in 2016 and CE marking in 2015. 

Meanwhile, MolecularMD said Health Canada has approved its PCR-based MRDx BCR-ABL test as an aid to monitor TKI treatment in Philadelphia chromosome positive CML patients, as well as for patients chronically treated with Novartis' Tasigna (nilotinib) who are candidates for discontinuation and monitoring of treatment-free remission. Patients in remission no longer taking Tasigna would continue to be monitored with MRDx BCR-ABL  — which is also FDA authorized and CE marked — to identify loss of molecular responses, MolecularMD noted.

Earlier this year, Portland, Oregon-based MolecularMD licensed the exclusive US marketing rights to the MRDx BCR-ABL test to Genoptix.

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