ISO/TS 4424:2023

FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 4424
ISO/TC 215/SC 1
Genomics informatics — Data
Secretariat: KATS
elements and their metadata for
Voting begins on:
2023-09-15 describing the tumor mutation burden
(TMB) information of clinical massive
Voting terminates on:
2023-11-10
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
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/DTS 4424:2023(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTS 4424:2023(E)
FINAL
TECHNICAL ISO/DTS
DRAFT
SPECIFICATION 4424
ISO/TC 215/SC 1
Genomics informatics — Data
Secretariat: KATS
elements and their metadata for
Voting begins on:
describing the tumor mutation burden
(TMB) information of clinical massive
Voting terminates on:
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
COPYRIGHT PROTECTED DOCUMENT
© ISO 2023
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
ISO copyright office
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
CP 401 • Ch. de Blandonnet 8
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
CH-1214 Vernier, Geneva
DOCUMENTATION.
Phone: +41 22 749 01 11
IN ADDITION TO THEIR EVALUATION AS
Reference number
Email: copyright@iso.org
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/DTS 4424:2023(E)
Website: www.iso.org
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
Published in Switzerland
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
ii
  © ISO 2023 – All rights reserved
NATIONAL REGULATIONS. © ISO 2023

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ISO/DTS 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 .
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ISO/CD TS DTS 4424
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ISO /TC 215/SC 1/WG 1
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Secretariat: KATS
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Date: 2023-09-01
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Genomics Informatics informatics — Data Elementselements and
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their Metadatametadata for Describingdescribing the Tumor
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Mutation Burdentumor mutation burden (TMB)
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Informationinformation of Clinical Massive Parallelclinical
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massive parallel DNA Sequencingsequencing
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CDInformatique génomique — Éléments de données et leurs métadonnées pour décrire les
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informations relatives à la charge tumorale mutationnelle (TMB) du séquençage massif parallèle d'ADN
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This document is not an ISO International Standard. It is distributed for review and comment. It is subject to
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change without notice and may not be referred to as an International Standard.
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Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of
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© ISO 2023 – All rights reserved

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ISO/CD TSDTS 4424:(E)
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© ISO 2023
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CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
Formatted: French (Switzerland)
EmailE-mail: copyright@iso.org
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Website: www.iso.orgwww.iso.org
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Published in Switzerland
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ISO/CD TS DTS 4424:(E)
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Contents
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Foreword . ix
Introduction . x
1 Scope . 1
2 Normative references . 1
3 Terms and definitions .
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