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The FDA-approved test that decides whether a person with acute myeloid leukaemia has a FLT3 mutation and so can be offered a FLT3 inhibitor.
Invivoscribe's LeukoStrat CDx FLT3 Mutation Assay was approved on 28 April 2017 (PMA P160040) as the companion diagnostic for midostaurin in acute myeloid leukaemia. Supplements added gilteritinib (28 November 2018) and quizartinib (20 July 2023). Invivoscribe also runs the test in its own LabPMM clinical laboratories.
Detects FLT3 internal tandem duplications (ITD) and the tyrosine kinase domain (TKD) mutations at D835 and I836 in DNA from peripheral blood or bone marrow. Connects to FLT3.
| Region | Year | Indication |
|---|---|---|
| US | 2017 | Companion diagnostic for midostaurin in acute myeloid leukaemia (FLT3 ITD and TKD) |
| US | 2018 | Companion diagnostic for gilteritinib |
| US | 2023 | Companion diagnostic for quizartinib |
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Query for this drug: (TITLE:"LeukoStrat CDx FLT3 Mutation Assay" OR ABSTRACT:"LeukoStrat CDx FLT3 Mutation Assay" OR TITLE:"LeukoStrat CDx FLT3" OR ABSTRACT:"LeukoStrat CDx FLT3") 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 LeukoStrat CDx FLT3 Mutation Assay, not a curated reading list.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics, Acute myeloid leukaemia and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics, Acute myeloid leukaemia and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares FLT3-TKD (D835 and I836 tyrosine kinase domain mutations), FLT3-ITD (internal tandem duplication) and the tag test.
Shares FLT3-TKD (D835 and I836 tyrosine kinase domain mutations), FLT3-ITD (internal tandem duplication) and the tag test.
Shares Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
Shares Companion diagnostic, Companion diagnostics and the tag test.
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