The Association for Molecular Pathology (AMP) 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. The manuscript, “Recommendations for Tumor Mutational Burden Assay Validation and Reporting: A Joint Consensus Recommendation of the Association for Molecular Pathology, College of American Pathologists, and Society for Immunotherapy of Cancer,” was released online ahead of publication in The Journal of Molecular Diagnostics.
ICI therapies have transformed patient care for a subset of individuals with multiple cancer types. As a result, there continues to be significant interest in predictive biomarkers, such as TMB, that can identify the patients more likely to benefit from these treatments. However, the calculation, reporting, and interpretation of TMB may vary across different laboratories. The AMP TMB Working Group was established to assess existing laboratory practices and develop evidence-based standards for the analytical validation and reporting of clinical TMB testing. These recommendations are intended to be a reference guide based on scientific literature, observational survey data, and the professional experience of the Working Group’s subject matter experts.
