– Macrogen is the first and only NGS-based institute in Korea to receive GCLP accreditation

– Increased demands from multinational pharmaceutical companies for NGS analysis for companion diagnostics and targeted anti-cancer drugs

– Expected growth in revenue by entering into the clinical trial market with a new profit model

SEOUL, South Korea–The precision medicine and biotechnology company, Macrogen (CEO Kap-Seok Yang, www.macrogen.com) announced on May 20 that it 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.”

“Macrogen has secured unrivaled competitiveness by acquiring all the major domestic and international certifications needed for clinical diagnosis,” CEO Yang added. “With these certifications as our foundation, we will put our best efforts forth to continue to nurture the clinical diagnostics business as a ‘future growth engine’ to become a ‘major portfolio’.”

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.

The global pharmaceutical market is a giant market with an annual worth of approximately USD 1 trillion and is considered to be a promising market with an annual expected growth rate of around 3–6%. In particular, the Korean market, along with the market in the United States, is expected to grow at an annual average rate of 4–7%. According to the MFDS’s statistics on trends in the food and drug industry in 2018, the size of Korea’s pharmaceutical market increased 1.55% up from the previous year to about USD 18.5 billion in 2017. Furthermore, according to the MFDS’s approval status of drug clinical trial plans, the number of approved trials in Korea has continued to increase over the past three years, with the number of approved clinical trials reaching 679 in 2018, up 3.2% from 658 in 2017.

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