Standard

ISO/TS 4424:2023

Published

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Abstract

This document identifies data elements and metadata to represent the information about tumor mutation burden (TMB) when reporting the value for the biomarker using clinical massive parallel DNA sequencing. This document covers the TMB status and related metadata such as mutation type, sequencing types, and target areas of sequencing from human samples for clinical practice and research. This document is not intended — to define experimental protocols or methods for calculating the value of tumor mutation burden, — for the other biological species, and — for the Sanger sequencing methods.

Document information

  • Standard from ISO
  • Published:
  • Edition: 1
  • Document type: TS
  • Pages
  • Publisher ISO
  • Distributor ISO
  • ICS 35.240.80
  • ISO TC ISO/TC 215/SC 1