OSR Holdings’ glucose monitor demonstrates accuracy and precision in pilot study

OSR Holdings (OSRH) announced the key findings from a company-sponsored pilot study conducted by Woori IO, an OSR company, in collaboration with Korea University Guro Hospital. The study evaluated the performance of the Glucheck blood glucose measurement system and validated its accuracy, stability, and usability across a representative participant group. The Glucheck system was tested against the AU5800 Chemistry Analyzer by Beckman Coulter as a baseline reference device. Over 90% of measurements across both device models achieved greater than or equal to 85% accuracy, with fewer than 8% falling below 74%. Repeatability was confirmed within a 5% coefficient of variation, demonstrating stable performance. Correlation coefficients exceeded 0.900 versus reference devices. All measurements were located within Zones A and B of the Clarke and Consensus Error Grids, thereby satisfying the acceptance criteria defined by ISO. While this study was not a regulatory trial, it provided scientific foundation that subsequently led to Samsung’s selection of Woori IO for its C-Lab Outside program. Building upon these results, Woori IO and Samsung are currently conducting a new PoC study, and a formal MFDS-compliant clinical trial is planned for the first half of 2026 at a leading Seoul medical center.