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

Oncology

Specialty

Pathology & Laboratory Medicine

DOI

10.1016/j.jmoldx.2024.05.002

Link to Full Text

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