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. 

***New for 2023-2024***

Following several publications highlighting the importance of the detection of FLT3 ITD MRD in acute myeloid leukaemia (1), we will be including FLT3 MRD samples in the MRD for AML by Molecular Methods (Pilot – Not Accredited) programme in the second trial issue of 2023-2024 (due March 2024). 

1. Grob T, Sanders MA, Vonk CM, Kavelaars FG, Rijken M, Hanekamp DW, et al. Prognostic Value of FLT3 -Internal Tandem Duplication Residual Disease in Acute Myeloid Leukemia. J Clin Oncol. 2022 Oct 31;JCO2200715.

To register for this programme, please click here.