■ Theragen Bio acquired NGS clinical laboratory certification for the first time in the domestic medical and industry under the name of Theragen Etex Bio Research Institute in 2017 and ISO 27701 for the first time in the world in the genome industry

■"In the process of developing accompanying diagnostic drugs and new drugs, demand for NGS analysis increases… Clinical-level NGS experimental process will be improved and the best quality will be provided in the future

Theragen Bio (CEO: Samuel Hwang), a global genome analysis service and AI-based new drug development company, was designated as a clinical trial sample analysis institution 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 number of domestic clinical trial sample analysis institutions designated by the Ministry of Food and Drug Safety was 201, and Theragen Bio is a clinical trial institution capable of NGS analysis, and it is known that it has passed the strict screening standards in the NGS field revised since February 2021.

Theragen Bio has also maintained the best rating in the genetic testing accuracy evaluation of the Korea Genetic Testing and Assessment Service since it obtained NGS clinical laboratory certification for the first time in Korea under the name of Theragen Etex Bio Research Institute in 2017. In addition, in July 2020, the company acquired the ISO27701 certification of the personal information protection management system (ISO27701) for the first time in the world, and its excellence in information security was also recognized externally.

Hwang Tae-soon, CEO of Theragen Bio, said, "In line with the recent clinical trend, we have obtained certification as a clinical trial specimen analysis institution. Above all, we will continue to supplement the system to more safely support clinical information of customers using NGS technology, he said. "We have completed the expansion of related laboratories this time in anticipation of a surge in demand for NGS analysis for clinical trials."

Meanwhile, the clinical trial specimen analysis institution is an institution that conducts specimen analysis tests for clinical trials. It is designated by the Director of Food and Drug Administration in accordance with the Pharmaceutical Affairs Act and the Regulations on Safety of Drugs by confirming the requirements of essential personnel and facilities, handling facilities such as laboratory and control substances, test work areas, data storage facilities, and management facilities. The designation system for a clinical trial specimen analysis institution was newly established in accordance with the revision of the Pharmaceutical Affairs Act announced on October 24, 2017. Sample analysis for clinical trial plan approval application (IND) conducted after October 25, 2018 must be obtained from a clinical trial sample analysis institution designated by the Ministry of Food and Drug Safety.

▶ Introduction of Theragen Bio

Theragen Bio provides genome service to more than 700 domestic medical and research institutes over 40 countries abroad, being as a global genome service provider and AI-based biopharmaceutical company specializing in the development of the fourth-generation personalized anti-cancer drugs. Theragenbio strives to realize precision medicine based on genomic technology, thereby providing the true hope and practical solutions for welfare and health of mankind.