During the recent ISO TC 212 Medical laboratories and in vitro diagnostic systems – WG 4 Microbiology and Molecular Diagnostics meeting held at the German Institute for Standardisation (DIN) from 12 to 14 June 2024, a significant proposal for a new international standard on “Design and Workflow Requirements for NGS-based Oncology Applications” was presented by the Singapore delegation.
The Singapore team was spearheaded by Dr Yiu-Lian Fong, Senior Scientific Advisor for MiRXES, and Dr Adrian Yeo, Chair of the Technical Committee for Biotechnology and Laboratory Testing and Convenor of the National Mirror Working Group for ISO TC 212. Joining them were Ms Yang Fan, Head of CoRE-SDO, and Mr Kevin Tan, Development Partner at Enterprise Singapore Standards Division.
The initiative, originally jointly proposed by MiRXES (Singapore) and BGI (China) under the auspices of the Singapore Standards Council (SSC), was first introduced to the ISO TC 212 WG 4 on 4 October 2023. Following valuable initial feedback, the joint team refined their proposal with insights from a WG 4 sub-team of international experts.
In Berlin, Dr Fong detailed the comprehensive scope of the proposed standard, addressing prior concerns. The enhanced scope covers key oncology applications, guided by CEN/TS 17981, and incorporates emerging analytes and clinical applications, such as methylation and miRNA for cancer screening or prognosis. Importantly, the guidelines are platform-agnostic, with bioinformatics guidelines tailored to each analyte and application.
The proposal received unanimous endorsement from the committee, which recommended advancing the project to the next stage. A detailed New Work Item Proposal will be presented at the upcoming WG 4 meeting in November 2024. Upon ISO TC 212’s endorsement, an international Project Working Team will be tasked with developing the standard.
The meeting at DIN, an organization with over 100 years of history and over 33,000 established standards, marks a pivotal step towards advancing international standards in next-generation sequencing (NGS) applications.
CoRE-SDO is anticipating hosting the next WG 4 meeting in Singapore and extends an invitation to local experts to join a focus group for ongoing consultation throughout the standard’s development lifecycle.