Measurable Residual Disease for AML by Molecular Methods (Pilot - Not Accredited)

Programme objective assess laboratories’ ability to accurately detect and quantify measurable residual disease (MRD) using the fusion genes: t(8;21) RUNX1::RUNX1T1, inv(16) CBFB::MYH11, and t(15;17) PML::RARA, canonical genomic variants in exon 11 of the NPM1 gene (NM_002520.7) and internal tandem duplications within the juxta membrane domain of FLT3 (NM_004119.3).

Clinical/scientific background MRD analysis is increasingly important in the management of acute myeloid leukaemia (AML) to predict prognosis and guide treatment plans.  It is used as a key outcome in clinical trials for new therapies, where it has the potential to accelerate drug assessment and approval. The phenotypic and genetic heterogeneity of acute myeloid leukaemia (AML), with a wide range of biomarkers, makes standardisation of MRD monitoring a challenge in AML.  To address this, the European LeukaemiaNet (ELN) MRD working group have developed consensus guidelines to standardise both flow cytometric and molecular genetic assessment of MRD.^1,2,3

Suitability Participation in this EQA programme is open to laboratories employing molecular genetic approaches for the identification and quantification of AML MRD targets.

All EQA programme communications, data entry, and reports will be conducted exclusively in the English language. Participants must ensure proficiency in English to fully engage in the programme.

The programme welcomes participation from:

• Clinical Healthcare Laboratories
• Academic and Research Institutions
• In Vitro Diagnostics (IVD) Manufacturers 
• Pharmaceutical Companies

Sample type/distribution Each round features a total of 12 lyophilised cell line based samples; three samples for each marker, two MRD ‘positive’ samples and an MRD ‘negative’ sample. There will be two rounds per annum. Participants are invited to register even if they don’t test all the markers featured in the programme.  Registration and result submission can be done on an individual marker basis.

Trial duration Trials for this programme are live/open for a minimum of 6 weeks. Please note, trials issued/closing in August or December are extended by 1 week. An automated email is sent 2 days prior to trial closure to any participant that has not yet returned results.

Subcontracted areas Pre-issue and post-closure testing of samples for this programme is subcontracted, although the final decision about sample suitability lies with the EQA provider. No other activities in relation to this EQA programme are subcontracted.

Updates to the programme for current or upcoming year A number of participants have expressed interest in MRD assessment of KMT2A rearrangements, therefore we plan to distribute samples for this marker in upcoming trials.

To register for this programme, please click here.

References

1. Cloos J, et al, 2026. 2025 update on MRD in acute myeloid leukemia: a consensus document from the ELN-DAVID MRD Working Party. Blood. 147(11):1147-1167. doi: 10.1182/blood.2025031480
2. Heuser M et al, 2021 Update on MRD in acute myeloid leukemia: a consensus document from the European LeukemiaNet MRD Working Party. Blood. 138(26):2753-2767. doi: 10.1182/blood.2021013626.
3. Schuurhuis GJ, et al, 2018. Minimal/measurable residual disease in AML: a consensus document from the European LeukemiaNet MRD Working Party. Blood. 131(12):1275-1291. doi: 10.1182/blood-2017-09-801498.