S. Korea's organoid evaluation technology adopted as ISO international standard

A South Korean technology that precisely measures — in numerical terms — how closely an organoid resembles an actual human organ has been adopted as an international standard. The development is expected to raise the reliability of drug efficacy and toxicity testing as well as regenerative therapy research by establishing a universal benchmark for organoid quality assessment, replacing the varying criteria previously used across laboratories worldwide.

The Korea Research Institute of Bioscience and Biotechnology said Wednesday that a joint research team led by Cho Hyun-su of its Stem Cell Convergence Research Center and Kim Dae-su of its Digital Biotech Research Center developed a quantitative evaluation technology that calculates, as a percentage score, how closely an organoid derived from human pluripotent stem cells resembles an actual human organ. The technology has now been established as an official international standard procedure.

Organoids are three-dimensional cell clusters that replicate the structure and physiological functions of human organs. Because they allow researchers to assess the efficacy and side effects of drug candidates without administering substances to actual patients, their applications are rapidly expanding — from disease research to drug development, toxicity testing and regenerative therapy.

Objectively comparing how faithfully an organoid reproduces a real organ had long been difficult, however. Existing methods relied mainly on qualitative assessments that biochemically confirmed differentiation markers for specific organs, and manufacturing protocols and evaluation criteria varied from one laboratory to another.

To address this, the research team integrated the entire process into a single unified framework — from data compilation and gene panel selection to gene data reliability and quality control, and finally similarity calculation. The technology expresses an organoid's differentiation and maturation level as a percentage relative to an actual human organ, enabling consistent quality assessment across different research institutions and companies.

The technology has been formally published as ISO/TS 24932, an official ISO technical specification, with the final version released in August. It marks the first time a domestically developed organoid quantitative evaluation technology has been established as an international standard procedure.

With the standard in place, researchers and pharmaceutical companies worldwide can evaluate and compare organoid quality using the same procedure. It is particularly expected to be used for quality control of organoids in toxicity and efficacy testing of drug candidates, cell therapy development, and ensuring the reliability of organoid-based testing services.

The standard currently adopted is a technical specification, a stage that sets out requirements and procedures for use in industrial and research settings as the technology continues to develop. It may be upgraded to a full international standard following further technical validation and international consensus.

"This formalizes the organoid similarity evaluation technology independently developed by KRIBB so that it can be used as a common tool in research and industrial settings around the world," Cho and Kim said. "It will make a significant contribution to improving the reliability of disease research and the development of new drugs and therapies."