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Development and Validation of Blood Tumor Mutational Burden Reference Standards

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"Development and Validation of Blood Tumor Mutational Burden Reference Standards"

Tumor mutational burden, as measured by exome or panel sequencing of tumor tissue (tTMB) or blood (bTMB), has been identified as a potential predictive biomarker for treatment benefit in patients with various cancer types receiving immunotherapy targeting checkpoint pathways (e.g. PD 1, PD L1, CTLA 4). However, significant variability in TMB measurement has been reported due to differences in pre-analytical and laboratory methods, panel size, number of genes covered, and bioinformatics pipelines

Reference standards have been proposed and evaluated for tTMB analysis by the Friends of Cancer Research TMB Harmonization Consortium to enable standardization across different NGS panel providers and to determine the correlation of panel TMB scores with WES TMB scores.

Reference standards for bTMB are likely to be even more important given the unique challenges and higher sensitivity required for bTMB assays.

Here we report the development of contrived bTMB reference materials using DNA from tumor cell lines and donor matched lymphoblastoid cell lines to support calibration and alignment across different laboratories and bTMB platforms.

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