Standardising the Future: The Journey and Impact of SS 656 on miRNA Diagnostics
The journey of SS 656 — Singapore’s first national standard for miRNA-based diagnostics—is a showcase in ecosystem synergy. It represents a seamless “bench-to-bedside” transition driven by three core organisations, using the development of GASTROClear as the definitive roadmap.
Until 2019, the development of RNA-driven molecular diagnostics lacked clear guidelines that could address technical gaps in pre-analytical variability and analytical inconsistencies. This created clinical risks of patient misclassification and screening errors.
SS 656 was developed as a direct response to this gap, by providing clear definition of clinical context, intended use, indications, and limitations before biomarker discovery, providing explicit guidance on controlling pre-analytical variables and formalising analytical validation for miRNA assays. ...