GC Genome Designated as 'Clinical Trial Specimen Analysis Institution' by MFDS

[Asia Economy Reporter Lee Gwan-joo] GC Genome announced on the 13th that it has been designated as a Good Clinical Laboratory Practice (GCLP) institution certified by the Ministry of Food and Drug Safety.

A clinical trial specimen analysis institution is an organization designated by the Ministry of Food and Drug Safety in accordance with the Pharmaceutical Affairs Act and the Regulations on the Safety of Pharmaceuticals, etc. To smoothly carry out specimen analysis tasks, essential personnel and facility deployment, regular education and training, receipt and handling facilities for clinical trial specimens, maintenance of equipment and facilities, and testing work areas must meet the required standards.

GC Genome can now expand not only its existing genomic big data AI-based clinical genome analysis business but also its clinical trial specimen analysis business.

Ki Chang-seok, CEO of GC Genome, said, “As a result of relentless investment in research and development (R&D) to strengthen cancer gene testing and AI liquid biopsy technology, we met the strict standards required by the Ministry of Food and Drug Safety and were designated as a GCLP institution. As the only domestic specialized clinical genome analysis institution conducting not only clinical tests for patient care but also clinical trial specimen analysis for new drug development, we will actively participate in the development of anticancer drugs and rare genetic disease new drugs, contributing to the advancement of the pharmaceutical industry both domestically and internationally.”

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