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. 2024 Jul;38(7):1638-1641.
doi: 10.1038/s41375-024-02275-x. Epub 2024 May 23.

Recommendations from the AML molecular MRD expert advisory board

Stuart Scott  1   2 , Alison Devonshire  3 , Richard Dillon  4   5 , Christian Thiede  6   7 , Nicholas C P Cross  8   9 , Helen E White  8   9 , Leandro Lo Cascio  10 , Katya Mokretar  11 , Nicola Potter  4 , Christopher S Hourigan  12 , Jerald Radich  13 , Adam Corner  14 , Véronique Laloux  15 , Gemma Halliday  16 , Daniel Dilks  17 , Tom Morrison  17 , Katelyn Gilmour  18 , Ashley Cartwright  19 , Liam Whitby  19
Affiliations

Recommendations from the AML molecular MRD expert advisory board

Stuart Scott et al. Leukemia. 2024 Jul.
No abstract available

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Conflict of interest statement

Whilst the diverse composition of the panel brought a breadth of expertise and perspectives, it also introduced potential conflicts of interest, particularly regarding the commercial providers. These entities may have a vested interest in the outcomes of the advisory panel due to their affiliations and the nature of their businesses. Each member has disclosed their respective affiliations with commercial bodies. The discussion was led by individuals from non-commercial entities and all recommendations and findings have been derived through consensus and with the commitment to advancing clinical and laboratory practice. These disclosures have been made explicit to uphold transparency and integrity in the reporting of the panel’s findings.

Figures

Fig. 1
Fig. 1
Comparison of interlaboratory variation for standardized BCR::ABL1IS RT-dPCR (gray triangle markers) and RT-qPCR (black triangle markers) [5] testing with unstandardized RUNX1::RUNX1T1 (blue circle markers), CBFB::MYH11 (red circle markers), PML::RARA (green circle markers) and NPM1 (orange circle markers) RT-qPCR testing [6].
Fig. 2
Fig. 2. Structure of a calibration hierarchy whereby patient results are traceable to higher order reference materials such as World Health Organisation (WHO) International Standard materials, through a series of linked calibrations.
An example of this is in the standardization of BCR::ABL1/reference gene ratio to the International Scale. Modified from ISO 17511:2020 Figure 4 model calibration hierarchy for “international conventional calibrator” that defines the quantity intended to be measured (“measurand”) [15]. IVD, in vitro diagnostic medical device. Created with BioRender.com.
See this image and copyright information in PMC

References

    1. Bhansali RS, Pratz KW, Lai C. Recent advances in targeted therapies in acute myeloid leukemia. J Hematol Oncol. 2023;16:1–27. doi: 10.1186/s13045-023-01424-6. - DOI - PMC - PubMed
    1. United States Food and Drug Administration. Hematologic Malignancies: Regulatory Considerations for Use of Minimal Residual Disease in Development of Drug and Biological Products for Treatment Guidance for Industry. 2020 Jan. United States Food and Drug Administration. Available from: https://www.fda.gov/regulatory-information/search-fda-guidance-documents... (accessed 4 Aug 2023).
    1. Schuurhuis GJ, Heuser M, Freeman S, Béné M-C, Buccisano F, Cloos J, et al. Minimal/measurable residual disease in AML: a consensus document from the European LeukemiaNet MRD Working Party. Blood. 2018;131:1275–91. doi: 10.1182/blood-2017-09-801498. - DOI - PMC - PubMed
    1. UK NEQAS LI Home Page - Measurable Residual Disease for AML by Molecular Methods (Pilot - Not Accredited). https://www.ukneqasli.co.uk/eqa-pt-programmes/molecular-haemato-oncology... (accessed 4 Aug 2023).
    1. Scott S, Cartwright A, Francis S, Whitby L, Sanzone AP, Mulder A, et al. Assessment of droplet digital polymerase chain reaction for measuring BCR-ABL1 in chronic myeloid leukaemia in an international interlaboratory study. Br J Haematol. 2021;194:53–60. doi: 10.1111/bjh.17521. - DOI - PubMed

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