Teragen Bio Designated as Clinical Trial Specimen Analysis Institution by MFDS

[Asia Economy Reporter Lee Gwan-joo] Theragen Bio announced on the 21st that it has been designated as a clinical trial specimen analysis institution by the Ministry of Food and Drug Safety.

With this designation, Theragen Bio can now perform next-generation sequencing (NGS) analysis on clinical trial specimens. As of this month, the total number of domestic clinical trial specimen analysis institutions designated by the Ministry of Food and Drug Safety is 201, and Theragen Bio passed the stringent evaluation criteria in the enhanced NGS field last February.

Theragen Bio, under the name Theragen Etex Bio Research Institute in 2017, was the first in the medical and industrial sectors in Korea to obtain NGS clinical laboratory certification. It has maintained the highest grade in the gene test accuracy evaluation by the Korea Institute of Genetic Testing Evaluation. In July 2020, to ensure the safe protection of customers' personal information, it became the first in the genomics industry worldwide to acquire the Personal Information Protection Management System certification (ISO27701), gaining external recognition for excellence in information security.

Hwang Tae-soon, CEO of Theragen Bio, said, “We will continue to improve our systems to support customers' clinical information more safely using NGS technology,” adding, “We expect a rapid increase in demand for NGS analysis for companion diagnostics and new drug development clinical trials, and have recently completed the expansion of related laboratories.”

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