CEN/TS 17981-1:2023, In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 1: Human DNA examination
CEN/TS 17981-2:2023, In vitro diagnostic Next Generation Sequencing (NGS) workflows — Part 2: Human RNA examination
These 2 CEN/TS documents, developed by CEN/TC 140 WG3 in the context of the Instand-NGS4P project, cover all the steps needed to obtain successful and reliable sequence results – the pre-examination phase (sample collection), over the examination phase (library preparation, sequencing), to the post-examination phase (analysis and reporting). Furthermore, both documents explain and apply the views on regulatory issues from the Regulation (EU) 2017/746 on In vitro Diagnostic Medical Devices (IVDR) and U.S. Food and Drug Administration (FDA) concerning NGS diagnostic quality issues.
Instand-NGS4P proudly reports that a first important step towards international standardization of NGS workflows has now been achieved, with the acceptance of the above documents as Approved Work Items in ISO/TC 212.
Further information on this Standardization work performed by Instand-NGS4P as well as how to get involved in the development of the ISO standards.
