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FDA-approved companion diagnostic

MRDx BCR-ABL Test

Quantitative RT-qPCR assay that measures BCR-ABL1/ABL1 transcript levels in blood from CML patients to monitor molecular response and support treatment-free remission decisions.

Lab-developed CDxMethod: PCRSpecimen: Whole bloodBiomarker: BCR-ABL1 transcript level (International Scale)
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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
K173492
Supplements
Manufacturer
MolecularMD Corporation (ICON Plc)
Approval date
December 22, 2017
Test specifications
Methodology
PCR
Specimen
Whole blood
Report format
Comprehensive report PDF
Turnaround (typical)
Not specified
Biomarker(s)
BCR-ABL1 transcript level (International Scale)
What this test is

MRDx BCR-ABL Test is an FDA-cleared, quantitative real-time RT-PCR assay that measures BCR-ABL1 and ABL1 transcript levels in RNA from peripheral blood of patients with Philadelphia chromosome–positive chronic myeloid leukemia. It reports BCR-ABL1/ABL1 on the International Scale to monitor response to tyrosine kinase inhibitor therapy and help identify patients who may be candidates for treatment discontinuation and treatment-free remission.

Where this test fits

IndicationBiomarkerBiomarker detailsTherapy (Select a therapy to open its FDA-approved testing pathway)
Chronic Myeloid Leukemia (CML)t(9;21) Philadelphia chromosomeBCR-ABL fusionTASIGNA

Performing lab

MolecularMD Corporation (ICON Plc)

Cambridge Lab (22D2048597)

This companion diagnostic is performed exclusively at Foundation Medicine's CLIA-certified, CAP-accredited laboratory.

Order this test

If your organization is connected to Casandra, you can place an electronic order forMRDx BCR-ABL Test 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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