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An FDA-cleared blood test that measures the BCR-ABL1 signal of chronic myeloid leukaemia, listed by the FDA as a companion to nilotinib.
MolecularMD's MRDx BCR-ABL Test was cleared on 22 December 2017 through the 510(k) route (K173492, decision 'substantially equivalent with drug') and appears on the FDA companion diagnostic list with nilotinib in chronic myeloid leukaemia, tested on peripheral blood. ICON plc announced on 21 February 2019 that it had acquired MolecularMD.
Measures BCR-ABL1 transcripts in peripheral blood; the FDA classifies it as a Bcr/Abl1 monitoring test. Connects to BCR::ABL1 (Philadelphia chromosome).
| Region | Year | Indication |
|---|---|---|
| US | 2017 | 510(k) clearance; companion to nilotinib in chronic myeloid leukaemia (peripheral blood) |
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Query for this drug: (TITLE:"MRDx BCR-ABL Test" OR ABSTRACT:"MRDx BCR-ABL Test") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about MRDx BCR-ABL Test, not a curated reading list.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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