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The FDA-approved test that finds an IDH1 mutation in acute myeloid leukaemia or myelodysplastic syndrome, which makes a person eligible for an IDH1 inhibitor.
Abbott Molecular's RealTime IDH1 was approved on 20 July 2018 (PMA P170041) as the companion diagnostic for ivosidenib in acute myeloid leukaemia. Supplements added olutasidenib in acute myeloid leukaemia (1 December 2022) and ivosidenib in myelodysplastic syndromes (24 October 2023). It reads blood or bone marrow, so no solid tumour sample is involved.
Detects the IDH1 R132 mutations R132C, R132H, R132G, R132S and R132L in DNA from peripheral blood or bone marrow. Connects to IDH1 / IDH2.
| Region | Year | Indication |
|---|---|---|
| US | 2018 | Companion diagnostic for ivosidenib in acute myeloid leukaemia (IDH1 R132 mutations) |
| US | 2022 | Companion diagnostic for olutasidenib in acute myeloid leukaemia |
| US | 2023 | Companion diagnostic for ivosidenib in myelodysplastic syndromes |
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Query for this drug: (TITLE:"Abbott RealTime IDH1" OR ABSTRACT:"Abbott RealTime IDH1") 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 Abbott RealTime IDH1, not a curated reading list.
Shares Abbott Laboratories, Companion diagnostic, Companion diagnostics and the tag test.
Shares IDH1 R132 mutation, Ivosidenib, Companion diagnostic, IDH1 / IDH2 and the tag test.
Shares Abbott Laboratories, Companion diagnostic, Companion diagnostics and the tag test.
Shares Abbott Laboratories, Companion diagnostic, Companion diagnostics 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 Companion diagnostic, Pathologic complete response (pCR), Companion diagnostics and the tag test.
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