Jonathan Nowak, MD, PhD
Molecular Pathologist
Center for Advanced Molecular Diagnostics
Brigham and Women's Hospital
Boston, Massachusetts, United States
Description: This session is based on new joint consensus recommendations from the Association for Molecular Pathology for the analytical validation and reporting of tumor mutational burden (TMB) testing as a potential predictive biomarker for immune checkpoint inhibitor (ICI) therapies. The AMP TMB Working Group, including organizational representation from the American Society of Clinical Oncology (ASCO), College of American Pathologists (CAP), and Society for Immunotherapy of Cancer (SITC), was established to assess existing laboratory practices and develop evidence-based standards for the analytical validation and reporting of clinical TMB testing. The recommendations, which 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, 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.
Learning Objectives:
1. Identify current challenges related to the adoption of TMB testing.
2. Discuss new consensus recommendations for TMB assay validation and test reporting.
If this session topic is of interest to you, please consider looking at the following course on AMP EDucation (AMPED™ Online)
Title: 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
Click here to learn more.
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For further information on Tumor Mutational Burden: Click here to learn more.
Breakout Speaker: Larissa V. Furtado, MD – St. Jude Children's Research Hospital
Panelist: Susan Hsiao, MD, PhD – Columbia University Irving Medical Center