Recommendations for Tumor Mutational Burden Assay Validation and Reporting

IF 3.4 3区医学 Q1 PATHOLOGY Journal of Molecular Diagnostics Pub Date : 2024-08-01 DOI:10.1016/j.jmoldx.2024.05.002

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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.

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肿瘤突变负荷测定验证和报告建议：分子病理学协会、美国病理学家学会和癌症免疫疗法学会的联合共识建议》（Association for Molecular Pathology, College of American Pathologists, and Society for Immunotherapy of Cancer）。

肿瘤突变负荷（TMB）已被认为是几种肿瘤类型免疫疗法反应的预测性生物标志物。目前有多家实验室提供 TMB 检测，但各实验室在 TMB 的计算、报告和解释方面存在很大差异。TMB 标准化工作正在进行中，但目前还没有关于 TMB 验证和报告的公开指南。认识到目前临床 TMB 检测所面临的挑战，分子病理学协会（Association for Molecular Pathology）召集了一个由美国临床肿瘤学会（American Society of Clinical Oncology）、美国病理学家学会（College of American Pathologists）和癌症免疫治疗学会（Society for the Immunotherapy of Cancer）的代表组成的多学科协作工作组，对围绕 TMB 的实验室实践进行审查，并根据调查数据、文献综述和专家共识，为 TMB 检测的分析验证和报告提出建议。这些建议涵盖了 TMB 分析的分析前、分析中和分析后因素，并强调了综合方法描述的相关性，以实现不同检测方法之间的可比性。

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来源期刊

Journal of Molecular Diagnostics 医学-病理学

CiteScore

8.10

自引率

2.40%

发文量

143

审稿时长

43 days

期刊介绍： The Journal of Molecular Diagnostics, the official publication of the Association for Molecular Pathology (AMP), co-owned by the American Society for Investigative Pathology (ASIP), seeks to publish high quality original papers on scientific advances in the translation and validation of molecular discoveries in medicine into the clinical diagnostic setting, and the description and application of technological advances in the field of molecular diagnostic medicine. The editors welcome for review articles that contain: novel discoveries or clinicopathologic correlations including studies in oncology, infectious diseases, inherited diseases, predisposition to disease, clinical informatics, or the description of polymorphisms linked to disease states or normal variations; the application of diagnostic methodologies in clinical trials; or the development of new or improved molecular methods which may be applied to diagnosis or monitoring of disease or disease predisposition.

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