# Abbott RealTime IDH1

Source: https://onco.cc/drugs/abbott-realtime-idh1/  
OnCo record `abbott-realtime-idh1` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Summary

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.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Abbott RealTime IDH1
- Modality: PCR companion diagnostic test (IDH1 mutations, blood or bone marrow)
- Mechanism: Detects the IDH1 R132 mutations R132C, R132H, R132G, R132S and R132L in DNA from peripheral blood or bone marrow.
- Approvals: 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

## Sources

- FDA PMA P170041: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170041
- FDA: List of cleared or approved companion diagnostic devices: https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools

## Connected records

- drugs: [Abbott RealTime IDH2](https://onco.cc/drugs/abbott-realtime-idh2/), [Ivosidenib](https://onco.cc/drugs/ivosidenib/), [Olutasidenib](https://onco.cc/drugs/olutasidenib/)
- biomarkers: [IDH1 R132 mutation](https://onco.cc/biomarkers/idh1-r132/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/), [Myelodysplastic syndromes / neoplasms (MDS)](https://onco.cc/cancers/mds/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [IDH1 / IDH2](https://onco.cc/targets/idh/)
- companies: [Abbott Laboratories](https://onco.cc/companies/abbott/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Pathologic complete response (pCR)](https://onco.cc/terms/pcr/)

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