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

Minimal/measurable residual disease (MRD) testing is increasingly utilised and accepted as standard of care to manage a range of different haematological malignancies. Its use as a surrogate outcome in clinical trials of new therapies is being explored, where it has the potential to accelerate drug assessment and approval. The phenotypic and genetic heterogeneity of acute myeloid leukaemia (AML) has limited the use of MRD in this context; however, the European LeukaemiaNet (ELN) MRD working group have recently published consensus guidelines to standardise both flow cytometric and molecular genetic MRD testing (Schuurhuis et al, 2018).

This new programme will assess laboratories’ ability to accurately detect and quantify MRD using the fusion genes: t(8;21) RUNX1::RUNX1T1, inv(16) CBFB::MYH11, and t(15;17) PML::RARA and canonical genomic variants in exon 11 of the NPM1 gene (NM_002520.7). 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 of the markers featured in the programme. 

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.

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.

***New for 2024-2025***

Registration by marker for MRD for AML by Molecular Methods
During registration for 2024/2025, participants will be asked to specify the markers they test in the Measurable Residual Disease in Acute Myeloid Leukaemia by Molecular Methods programme. (t(8;21) RUNX1::RUNX1T1, inv(16) CBFB::MYH11, t(15;17) PML::RARA, NPM1 gene, and FLT3). Participants will only be shipped the samples they require for testing which will reduce plastic waste. Costing will be tiered based on how many markers participant’s test. 

To register for this programme, please click here.