Macrogen, a local biotechnology company, announced Wednesday that it has acquired the CAP (College of American Pathologists) certification in the field of diagnostic next-generation sequencing using NGS (Next Generation Sequencing) technology.
CAP certification has been an evaluation program since 1961, a certification body for U.S. clinical pathology testing. The program evaluates whether the quality control is being performed at all stages of providing clinical tests to patients. To obtain it the certificate, one must pass the accuracy test and the on-site verification of the inspection team.
The Macrogen마크로젠 Clinical Laboratory in Maryland, U.S., has passed all of the accuracy testing as well as the on-site verification procedures of the professional team to obtain the final certification, the company said.
In particular, it has received high marks in leadership, innovation, and outstanding standards, and has been recognized for excellence in quality control, staff qualifications, equipment, facilities and safety programs for laboratory records and procedures over the past two years.
Macrogen is the first company in Korea to receive the Clinical Laboratory Improvement Amendments (CLIA) certification in the United States through its U.S. subsidiary in 2013 and provides “Clinical Diagnosis Sequencing Service” to leading hospitals.
Since Macrogen was registered as a genetic testing agency in 2005, the company has maintained an A rank, which means that it has been establishing the best quality control system for clinical laboratories in the genetic testing accuracy evaluation of the Korea Institute of Genetic Information. Also, it received the "NGS Clinical Laboratory Certification" from the Ministry of Food and Drug Safety in April, and has secured the highest degree of reliability in equipment, reagents, facilities, workforce and inspection ability in the clinical laboratory in Korea.
"Macrogen has maintained a stringent international quality service management system for all clinical diagnostic services after obtaining CLIA certification in the U.S. in 2013,” said Chong Hyun-yong정현용, CEO of Macrogen. "We are pleased to confirm the technology and excellence once again with the CAP certification.”
He went on to say, “We will also provide more reliable service by obtaining US CAP and CLIA certification for Korean head office inspection center.”
Meanwhile, Macrogen is conducting the relevant procedures for acquiring the CAP certification for the first half of next year for the NGS Clinical Laboratory of the head office, and the Macrogen Precision Medical Center in the Seoul National University Bundang Hospital Healthcare Innovation Park.
Upon completion of the certification, it is expected that the Macrogen clinical diagnosis service and personal genome analysis service will expand into the domestic market and further accelerated entry into the global market.