Theragen Bio (CEO Hwang Tae-soon), a global genome analysis service and AI-based new drug development company, was designated as a clinical trial sample analysis agency designated by the Ministry of Food and Drug Safety on the 14th.
With this designation, Theragen Bio will be able to conduct NGS (Next Generation Sequencing) analysis of clinical trial samples. As of April 2022, the total number of domestic clinical trial sample analysis institutions designated by the Ministry of Food and Drug Safety is 201. Theragen Bio is a clinical trial institution capable of NGS analysis and is known to have passed the strict review standards in the NGS field, which have been revised since February 2021.
Theragen Bio acquired the first NGS clinical laboratory certification in the medical and industrial fields in Korea under the name of Theragen Etex Bio Research Institute in 2017 and has maintained the highest rating in the genetic testing accuracy evaluation of the Korea Institute of Genetic Testing and Evaluation. In addition, in July 2020, in order to safely protect customers’ personal information, the company acquired the personal information protection management system (ISO27701) certification for the first time in the genome industry in the world, and its excellence in information security has also been recognized externally.
Taesun Hwang, CEO of Theragen Bio, said, “In line with recent clinical trends, we have acquired certification as a clinical trial sample analysis agency. Above all, we plan to continue to supplement the system in the future to more safely support the clinical information of customers using NGS technology,” he said. “We expect the demand for NGS analysis for companion diagnostic medicine and new drug development clinical trials to increase rapidly in the future, so we have “The expansion of the laboratory has also been completed,” he said.
Meanwhile, a clinical trial sample analysis agency is an organization that conducts sample analysis tests for clinical trial subjects. This includes the arrangement of essential personnel and facilities to carry out the work of sample analysis, handling facilities such as experimental materials and control materials, test work areas, data storage facilities, and management facilities, etc. to ensure compliance with the ‘Pharmaceutical Affairs Act’ and ‘Drugs, etc. Designated by the Minister of Food and Drug Safety in accordance with the ‘Rules on Safety’.
The clinical trial sample analysis institution designation system is a new system established in accordance with the amendment to the Pharmaceutical Affairs Act announced on October 24, 2017. Sample analysis for clinical trial approval applications (INDs) conducted after October 25, 2018 must be received from a clinical trial sample analysis agency designated by the Ministry of Food and Drug Safety.
Source: Pangyo Techno Valley Official Newsroom
→ Go to ‘Asia Innovation Hub Pangyo Techno Valley 2022’ news