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FDA-approved companion diagnostic

Abbott RealTime IDH2

Real-time PCR assay that detects nine IDH2 R140 and R172 mutations in blood or bone marrow to help identify AML patients for IDH2-targeted therapies.

IVD-developed CDxMethod: PCRSpecimen: Whole blood, Bone marrowBiomarker: IDH2
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Ordering is available where Casandra has an active integration with the performing lab. Labs that offer this test can connect with us to enable digital ordering.

About this test

FDA approval details
PMA number
P170005
Supplements
Manufacturer
Abbott Molecular, Inc.
Approval date
August 1, 2017
Test specifications
Methodology
PCR
Specimen
Whole blood, Bone marrow
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
IDH2
What this test is

Abbott RealTime IDH2 is an in vitro real-time PCR assay for the qualitative detection of nine IDH2 mutations (R140 and R172 codons) in DNA from EDTA whole blood or bone marrow. Used on the Abbott m2000rt System, it reports mutation detected/not detected to support identification of AML patients with IDH2-mutated disease who may be candidates for IDH2-targeted therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Acute Myeloid Leukemia (AML)IDH2R140Q, R140L, R140G, R140W, R172K, R172M, R172G, R172S, and R172WIDHIFA

IVD Manufacturer

Abbott Molecular, Inc.

Abbott Molecular is a leader in molecular diagnostics — the analysis of DNA and RNA at the molecular level. Its tests can detect subtle genetic and chromosomal changes that may aid earlier diagnosis, guide therapy selection, and help monitor disease progression.

Order this test

If your organization is connected to Casandra, you can place an electronic order forAbbott RealTime IDH2 directly from your existing workflow.

Casandra connects providers, labs, and sponsored programs so that companion diagnostics can be ordered consistently and documented cleanly, regardless of which system you start from.

CDxTests.com is an informational resource for providers. Always refer to the official FDA labeling and laboratory documentation when making treatment decisions.

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