[Guideline development for MRD diagnostics in AML as a blueprint for solid tumors].

BACKGROUND

In acute myeloid leukemia (AML), the monitoring of measurable residual disease (MRD) has evolved over the past two decades from predominantly prognostic supplementary information to a central tool for risk stratification, treatment planning, and study endpoint definition. This development has been closely linked to advances in diagnostic technologies (multiparameter flow cytometry, qPCR/dPCR, next-generation sequencing) and international standardization initiatives.

AIMS: This review aims to assess the evolution of MRD recommendations for AML over the past decade, identify key developmental milestones, and evaluate their relevance for cfDNA/ctDNA-based MRD approaches in solid tumors.

MATERIAL AND

METHODS

This is a narrative review article.

RESULTS AND DISCUSSION: The 2018 European LeukemiaNet (ELN) recommendations for the first time established a widely accepted framework for minimum technical standards and reporting for measurable disease monitoring in AML. The 2021 update further integrated these technical recommendations into clinical decision-making and established consistent definitions, including those for MRD response and MRD relapse. The 2025 update of the ELN-DAVID network represents a comprehensive revision, as MRD recommendations are now systematically formulated along the lines of the genetic ELN 2022 risk groups and AML subtypes. In parallel, ultrahigh-sensitivity, error-corrected NGS approaches (UHS-NGS) have opened up new applications for MRD. For pathological diagnostics, AML can be seen as a model disease, since the standards established over many years for pre-analytics, analytical validation, cut-offs, longitudinal interpretation, quality assurance, and interdisciplinary implementation represent a blueprint for current cfDNA/ctDNA-based MRD strategies in solid tumors.