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ISO/TS 4424:2023

Genomics informatics — Data elements and their metadata for describing the tumor mutation burden (TMB) information of clinical massive parallel DNA sequencing

Publication date:   Dec 11, 2023

General information

60.60 Standard published   Dec 11, 2023

ISO

ISO/TC 215/SC 1 Genomics Informatics

Technical Specification

35.240.80   IT applications in health care technology

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Scope

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.

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PUBLISHED
ISO/TS 4424:2023
60.60 Standard published
Dec 11, 2023