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Macrogen Receives South Korean Accreditation

NEW YORK (GenomeWeb) – South Korea's Macrogen announced recently that it received Good Clinical Laboratory Practice accreditation from that country's Ministry of Food and Drug Safety (MFDS.)

GCLP is a quality standard for labs that analyze blood and urine sample for clinical trials, Macrogen said. The designation will enable the firm to perform next-generation sequencing analyses on clinical trial samples. The firm said in a statement that it is the first and only lab in South Korea that is able to work with NGS on such samples.

As a result of its position, the firm said it expects "to attract, as potential clients, domestic, and multinational pharmaceutical companies that develop drugs for the Korean market," especially new anti-cancer drug candidates along with companion diagnostics.

"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," Macrogen CEO Kap-Seok Yang said in a statement.

Macrogen registered as a genetic testing agency in 2005 and in 2017 it acquired NGS Clinical Laboratory certification from MFDS. The firm has also obtained CAP and CLIA accreditation for its NGS Clinical Labs and Bundang Precision Medicine Center. In February, the firm obtained GMP certification for its NGS-based in vitro diagnostic reagent production facility.

According to Macrogen, South Korean law requires that all clinical trial sample analyses be conducted by an accredited lab authorized by the MFDS.