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Standards Development
This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes including human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examined sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma.
NOTE 1 Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses.
This document addresses in vitro diagnostic examinations including laboratory developed examinations and is applicable to medical laboratories, molecular pathology laboratories and molecular genetic laboratories, in vitro diagnostic developers and manufacturers, biobanks as well as institutions and organizations performing biomedical research or sequencing services.
This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis.
NOTE 2 International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.
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