– NGS Clinical Laboratories in Seoul headquarters and Bundang
Precision Medicine Center Simultaneously Received the CAP Accreditation
Expected to Expand the Clinical Diagnostics Market in Korea and
Accelerate Entry into the Global Market
SEOUL, South Korea–(BUSINESS WIRE)–#CAPAccreditation–Macrogen, Inc. (CEO Kap-Seok Yang, www.macrogen.com)
(KOSDAQ: 038290), a precision medicine biotechnology company, announced
on August 13 that its two next generation sequencing (NGS) clinical
laboratories, located in its Seoul headquarters and Bundang Precision
Medicine Center, respectively, received the College of American
Pathologists (CAP) accreditation.
Macrogen now has three global NGS clinical laboratories with
international accreditation, including Macrogen USA, which was
CAP-accredited in October 2017.
The CAP Laboratory Accreditation Program is internationally recognized
and the largest of its kind, accrediting more than 8,000 laboratories.
As part of the program, laboratories undergo an on-site inspection once
every two years. Inspectors, who are practicing laboratory
professionals, use detailed checklists that reflect the program’s
rigorous standards and serve as a guide to assess the laboratory’s
overall management and operation.
Macrogen was CAP-accredited for genome analysis using NGS. The
accreditation qualifies the company to provide genetic testing services
that conform to the global standard across its clinical diagnostics
business. Such services include Non-Invasive Prenatal Test (NIPT),
Cancer Panel, BRCA1/2 Panel, Hereditary Cancer Panel, and Whole Exome
Since 2005, when Macrogen was registered as a genetic testing
institution, it has maintained the highest grade in the “Genetic Testing
Accuracy Evaluation” by the Korean Institute of Genetic Testing
Evaluation. On top of that, in April 2017, “NGS clinical laboratory
accreditation” by the Ministry of Food and Drug Safety officially
recognized that Macrogen has the outstanding quality management system.
“The CAP-accreditation of our two additional clinical NGS laboratories
is the result of our continuing commitment for the highest quality
management system,” said Kap-Seok Yang, the CEO of Macrogen. “We
consider this accreditation as the recognition of the laboratories’
expertise, transparency, and reliability, and hopefully it will help the
company expand its clinical diagnostics and personal genome sequencing
services in the Korean market and accelerate entry into the global
market.” he added.
Macrogen has continued investments and R&D activities with the aim to
expand the use of genome information to the clinical diagnostics and
consumer markets based on its global technology leadership in the genome
analysis field. It has launched many services ranging from ‘faest™’
(next-generation prenatal genome testing) to the ‘axen™ Cancer Panel’ (a
cancer genome testing service based on NGS) and ‘My Genomestory™’ (a
personal genome analysis service in the disease prediction and wellness
fields). Macrogen, a pioneer in the precision medicine field, is
strengthening its foundation for future business by cooperating with
major Korean and overseas medical institutions such as the Seoul
National University Bundang Hospital, National Cancer Center and many
experienced companies in various fields.
About CAP (College of American Pathologists)
As the world’s largest organization of board-certified pathologists and
leading provider of laboratory accreditation and proficiency testing
programs, the College of American Pathologists (CAP) serves patients,
pathologists, and the public by fostering and advocating excellence in
the practice or pathology and laboratory medicine worldwide. For more
information, read the CAP Annual Report at cap.org