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BSI PD ISO/TS 4424:2023 2024

BSI PD ISO/TS 4424:2023 2024

$142.49

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

Published By Publication Date Number of Pages
BSI 2024 30
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PDF Catalog

PDF Pages PDF Title
2 undefined
7 Foreword
8 Introduction
9 1 Scope
2 Normative references
3 Terms and definitions
12 4 Abbreviated terms
13 5 Tumor mutation burden (TMB)
14 6 Composition of elements for describing TMB on the clinical DNA NGS report
6.1 General
6.2 Summary part
6.3 Detail part
7 Fields and their nomenclature of required data
7.1 General
15 7.2 Clinical sequencing order
7.2.1 General
7.2.2 Clinical sequencing order code
7.2.3 Date and time
16 7.3 Information on subject of care
7.3.1 General
7.3.2 Subject of care identifier
7.3.3 Subject of care name
7.3.4 Subject of care birth date
7.3.5 Subject of care sex
17 7.3.6 Referring diagnosis
7.4 Information on legally authorized person ordering clinical sequencing
7.4.1 General
7.5 Performing laboratory
7.5.1 General
7.5.2 Basic information on performing laboratory
7.5.3 Information on report generator
7.5.4 Information of legally confirmed person on sequencing report
7.6 Biospecimen information
7.6.1 General
7.6.2 Type of specimen
18 7.7 TMB status result information
7.7.1 General
7.7.2 TMB value
7.7.3 TMB status
7.8 Recommended treatment
7.8.1 General
7.8.2 Medication
7.8.3 Clinical trial information
7.8.4 Other recommendation
19 7.8.5 Supporting information
8 Fields and their nomenclature of optional data
8.1 General
20 8.2 Reference genome version
8.3 TMB information
8.3.1 General
8.3.2 Criteria of TMB status
8.3.3 Approach of filtering germline variants
8.3.4 Variant types used for calculating TMB value
8.3.5 TMB region covered
8.3.6 Calibrated TMB value
21 8.4 Sequencing information
8.4.1 Clinical sequencing date
8.4.2 Sequencing type
8.4.3 Quality control metrics
8.4.4 Sequencing platform information
22 8.4.5 Analysis platform information
24 Annex A (informative) Example structure of TMB report
28 Bibliography

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BSI PD ISO/TS 4424:2023 2024
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