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FDA-approved companion diagnostic

Abbott RealTime IDH1

Real-time PCR assay that qualitatively detects IDH1 R132 mutations in blood or bone marrow to help identify patients eligible for IDH1-targeted therapies.

IVD-developed CDxMethod: PCRSpecimen: Whole blood, Bone marrowBiomarker: IDH1
Ready to order?

Casandra.ai provides a unified ordering experience so you can request this test directly from the performing lab, without changing your workflow.

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
P170041
Supplements
S006, S007
Manufacturer
Abbott Molecular, Inc.
Approval date
July 20, 2018
Test specifications
Methodology
PCR
Specimen
Whole blood, Bone marrow
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
IDH1
What this test is

Abbott RealTime IDH1 is an in vitro real-time PCR assay that qualitatively detects five IDH1 R132 mutations (R132C/H/G/S/L) in DNA from EDTA blood or bone marrow. Run on the Abbott m2000rt System, it reports a positive or negative result to support identification of patients with IDH1-mutated myeloid malignancies who may be candidates for IDH1-targeted therapies.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Acute Myeloid Leukemia (AML)IDH1R132 mutations (R132C, R132H, R132G, R132S, and R132L)REZLIDHIA, TIBSOVO
Myelodysplastic Syndromes (MDS)IDH1R132 mutations (R132C, R132H, R132G, R132S, and R132L)TIBSOVO

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 IDH1 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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