The Association for Molecular Pathology (AMP) has published a set of evidence-based recommendations for the analytical validation and reporting of tumor mutational burden (TMB) testing as a potential predictive biomarker for immune checkpoint inhibitor (ICI) therapies. These recommendations encompass pre-analytical, analytical, and post-analytical factors of TMB analysis, and emphasize the importance of comprehensive methodological descriptions in publications to allow comparability between assays.
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