Macrogen has received GCLP (Good Clinical Laboratory Practice) accreditation from the Ministry of Food and Drug Safety (MFDS) in Korea.
The GCLP is a quality standard for laboratories that analyze blood and urine samples for clinical trials. By law in Korea, only an institution that meets certain requirements in terms of facilities and manpower can be GCLP accredited and assigned as an official test institution by the Minister of the MFDS.
With its new designation, Macrogen will be able to perform NGS (Next Generation Sequencing) analysis of clinical trial samples. Currently, Macrogen is the first and only GCLP accredited institute that can provide clinical sample analysis reports using NGS technology.
The MFDS has made it mandatory for any clinical trial sample analyses, conducted after 25th of October 2018, must be conducted by a GCLP accredited test institute, authorized by the MFDS.
Given its unique designation, Macrogen is expected to attract, as potential clients, domestic and multinational pharmaceutical companies that develop drugs for the Korean market. In particular, Macrogen's NGS analysis report is expected to be used as reliable data for testing the clinical effects of new companion diagnostics and anti-cancer drug candidates that are developed based on the genome analysis.
"As the pharmaceutical industry became aware of Macrogen’s impending designation as an authorized institute, reservation inquiries for NGS analyses by multinational pharmaceutical companies have continued to increase," said Kap-Seok Yang, CEO of Macrogen. "This designation gives Macrogen a strong foothold in the pharmaceutical market, specifically in the clinical trial market, and this means that there is a huge potential for Macrogen to generate new revenue."
Since registering as a Genetic Testing Agency in 2005, Macrogen has maintained the highest grade in the genetic testing accuracy assessment of Korean Institute of Genetic Testing Evaluation. In April 2017, Macrogen acquired ‘NGS Clinical Laboratory’ certification from the MFDS, and in August and December of 2018, respectively, it obtained CAP accreditation and CLIA accreditation for its NGS Clinical Labs at the Macrogen Headquarters and the Bundang Precision Medicine Center. In February 2019, when Macrogen obtained GMP certification for its NGS-based in vitro diagnostic reagent production facility, it acquired the last of all the necessary certifications in the clinical diagnostics field and once again proved its technological prowess.