Tumor mutational burden (TMB), defined as the number of nonsynonymous somatic mutations acquired by a tumor genome, is increasingly used as a biomarker to distinguish between likely responders and non responders to immune checkpoint inhibitor (ICI) therapies.
Since TMB is not a binary biomarker, an ideal TMB threshold above which ICI treatment should be administered is sought. However, TMB measurement by next generation sequencing (NGS) is highly dependent on several factors including gene content, target region size, sequencing platform, and bioinformatic analysis. Consequently, there is a need for the development and availability of reference standards to implement and harmonize TMB measurements derived from different NGS assays.
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