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.
摘要：
肿瘤突变负荷（TMB）已被认为是几种肿瘤类型中免疫疗法反应的预测性生物标志物。几个实验室提供TMB测试，但是TMB的计算方式存在很大差异，报告,并在实验室中解释。TMB标准化工作正在进行中，但目前尚无已发布的TMB验证和报告指南。认识到临床TMB测试的当前挑战，分子病理学协会召集了一个多学科合作工作组，由美国临床肿瘤学会代表，美国病理学家学院，和癌症免疫治疗协会审查围绕TMB的实验室实践，并根据调查数据为TMB测试的分析验证和报告制定建议，文献综述，专家共识。这些建议包括预分析，分析，以及TMB分析的分析后因素，并强调全面的方法学描述的相关性，以允许测定之间的可比性。
