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.
Publication Title
The Journal of molecular diagnostics : JMD
Document Type
Article
Publication Date
8-1-2024
Keywords
oregon; portland; ppmc; Humans; Neoplasms; Biomarkers, Tumor; Mutation; Immunotherapy; Pathology, Molecular; Consensus; Societies, Medical; United States; Pathologists; Reproducibility of Results; DNA Mutational Analysis
Abstract
Tumor mutational burden (TMB) has been recognized as a predictive biomarker for immunotherapy response in several tumor types. Several laboratories offer TMB testing, but there is significant variation in how TMB is calculated, reported, and interpreted among laboratories. TMB standardization efforts are underway, but no published guidance for TMB validation and reporting is currently available. Recognizing the current challenges of clinical TMB testing, the Association for Molecular Pathology convened a multidisciplinary collaborative working group with representation from the American Society of Clinical Oncology, the College of American Pathologists, and the Society for the Immunotherapy of Cancer to review the laboratory practices surrounding TMB and develop recommendations for the analytical validation and reporting of TMB testing based on survey data, literature review, and expert consensus. These recommendations encompass pre-analytical, analytical, and postanalytical factors of TMB analysis, and they emphasize the relevance of comprehensive methodological descriptions to allow comparability between assays.
Clinical Institute
Cancer
Specialty/Research Institute
Oncology
Specialty/Research Institute
Pathology & Laboratory Medicine
DOI
10.1016/j.jmoldx.2024.05.002
