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.
This programme will be available for registration when registration opens 1st February 2022.