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IDH1

Biomarker

IDH1 mutations alter cellular metabolism and epigenetic regulation. These mutations are actionable in gliomas and certain hematologic malignancies.

Approvals
5
Indications
4
Therapies
3
Mapped tests
2

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where IDH1 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Acute Myeloid Leukemia (AML)
Heme · Leukemia
  • R132 mutations (R132C, R132H, R132G, R132S, and R132L)
REZLIDHIATIBSOVO
Astrocytoma and Oligodendroglioma
Solid Tumor · Brain
  • IDH1 R132C, IDH1 R132G, IDH1 R132H, IDH1 R132L, IDH1 R132S, IDH2 R172M, IDH2 R172K, IDH2 R172W, IDH2 R172S, and IDH2 R172G mutations
VORANIGO
Cholangiocarcinoma
Solid Tumor · Bile Duct
  • Single nucleotide variants
TIBSOVO
Myelodysplastic Syndromes (MDS)
Heme · Bone Marrow
  • R132 mutations (R132C, R132H, R132G, R132S, and R132L)
TIBSOVO
Tumor-agnostic approvals

Approvals defined at the solid tumor level where IDH1 is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report IDH1 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
Abbott RealTime IDH1
Abbott Molecular, Inc.
Method
PCR
Specimen
Whole blood

Reports IDH1 as part of its biomarker panel.

3 approvalsView test profile →
Test
Oncomine Dx Target Test
Life Technologies Corporation
Method
NGS
Specimen
Tissue (FFPE)

Reports IDH1 as part of its biomarker panel.

2 approvalsView test profile →
This view is scoped to IDH1. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.