# MRDx BCR-ABL Test

Source: https://onco.cc/drugs/mrdx-bcr-abl/  
OnCo record `mrdx-bcr-abl` (Test). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

An FDA-cleared blood test that measures the BCR-ABL1 signal of chronic myeloid leukaemia, listed by the FDA as a companion to nilotinib.

## Summary

MolecularMD's MRDx BCR-ABL Test was cleared on 22 December 2017 through the 510(k) route (K173492, decision 'substantially equivalent with drug') and appears on the FDA companion diagnostic list with nilotinib in chronic myeloid leukaemia, tested on peripheral blood. ICON plc announced on 21 February 2019 that it had acquired MolecularMD.

## Fields

- Kind: Test
- Status: approved
- Last checked: 2026-11-03
- Tags: test
- Brand: MRDx BCR-ABL Test
- Modality: BCR-ABL1 monitoring test (blood)
- Mechanism: Measures BCR-ABL1 transcripts in peripheral blood; the FDA classifies it as a Bcr/Abl1 monitoring test.
- Approvals: US 2017: 510(k) clearance; companion to nilotinib in chronic myeloid leukaemia (peripheral blood)

## Sources

- FDA 510(k) K173492: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K173492
- 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
- ICON acquires MolecularMD (21 February 2019): https://www.iconplc.com/news-events/press-releases/icon-acquires-molecularmd

## Connected records

- biomarkers: [BCR::ABL1 transcript (Philadelphia chromosome, quantitative PCR)](https://onco.cc/biomarkers/bcr-abl1-transcript/)
- cancers: [Chronic myeloid leukaemia (CML)](https://onco.cc/cancers/cml/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/)
- targets: [BCR::ABL1 (Philadelphia chromosome)](https://onco.cc/targets/bcr-abl/)
- drugs: [Nilotinib](https://onco.cc/drugs/nilotinib/)
- companies: [MolecularMD](https://onco.cc/companies/molecularmd/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/)

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