# Abbott RealTime IDH2

Source: https://onco.cc/drugs/abbott-realtime-idh2/  
OnCo record `abbott-realtime-idh2` (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 IDH2 mutation in acute myeloid leukaemia, the gateway to enasidenib.

## Summary

Abbott Molecular's RealTime IDH2 was approved on 1 August 2017 (PMA P170005) as the companion diagnostic for enasidenib in acute myeloid leukaemia. It reads blood or bone marrow.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: Abbott RealTime IDH2
- Modality: PCR companion diagnostic test (IDH2 mutations, blood or bone marrow)
- Mechanism: Detects the IDH2 mutations R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S and R172W in DNA from peripheral blood or bone marrow.
- Approvals: US 2017: Companion diagnostic for enasidenib in acute myeloid leukaemia (IDH2 R140 and R172 mutations)

## Sources

- FDA PMA P170005: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P170005
- 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 IDH1](https://onco.cc/drugs/abbott-realtime-idh1/), [Enasidenib](https://onco.cc/drugs/enasidenib/)
- biomarkers: [IDH2 mutation (R140 and R172)](https://onco.cc/biomarkers/idh2-mutation/)
- cancers: [Acute myeloid leukaemia](https://onco.cc/cancers/aml/)
- 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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