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SPECIFICATION 4424
First edition
2023-12
Genomics informatics — Data
elements and their metadata for
describing the tumor mutation burden
(TMB) information of clinical massive
parallel DNA sequencing
Informatique génomique — Éléments de données et leurs
métadonnées pour décrire les informations relatives à la charge
tumorale mutationnelle (TMB) du séquençage massif parallèle d'ADN
Reference number
ISO/TS 4424:2023(E)
© ISO 2023
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ISO/TS 4424:2023(E)
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© ISO 2023
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Published in Switzerland
ii
© ISO 2023 – All rights reserved
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ISO/TS 4424:2023(E)
Contents Page
Foreword .v
Introduction . vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Abbreviated terms . 4
5 Tumor mutation burden (TMB) .5
6 Composition of elements for describing TMB on the clinical DNA NGS report .6
6.1 General . 6
6.2 Summary part . 6
6.3 Detail part . 6
7 Fields and their nomenclature of required data . 6
7.1 General . 6
7.2 Clinical sequencing order . . 7
7.2.1 General . 7
7.2.2 Clinical sequencing order code . 7
7.2.3 Date and time . 7
7.3 Information on subject of care . 8
7.3.1 General .
...