SEOUL, South Korea–The precision medicine and biotechnology company, Macrogen (CEO Kap-Seok Yang, www.macrogen.com) (KOSDAQ: 038290), announced on December 20 that its NGS clinical laboratories in Seoul headquarters and Bundang Precision Medicine Center had officially received CLIA (Clinical Laboratory Improvement Amendments) accreditation, as the first in Korea.
The CLIA regulations establish quality standards for laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The certification is legally mandated for all laboratories and diagnostic equipment used for clinical testing in the United States and is recognized as an international standard.
Macrogen’s CLIA accreditation for its headquarters and Bundang Precision Medicine Center comes following its CAP (College of American Pathologists) accreditation in August. With the addition of the second accreditation, Macrogen became the only NGS clinical laboratory in Korea with both CLIA and CAP. Also, it further solidifies Macrogen’s reputation as a global leader in using NGS technology for clinical diagnostics, and recognizes that Macrogen possesses the leading technologies and competencies to enter the global clinical diagnostics market.
Macrogen received CLIA accreditation for its genomic analysis using NGS (Next Generation Sequencing). With the new certification, Macrogen is now able to provide genomic testing services that comply with global standards via its clinical diagnostic services, such as non-invasive prenatal testing (NIPT), hereditary cancer panels (BRCA 1/2 panel), somatic cancer panels, and whole exome sequencing.
“The CLIA accreditation allows us to test clinical samples from the United States and various countries worldwide in Korea; this gives us an advantage in building genome big data with medical institutions throughout the world,” said Kap-Seok Yang, the CEO of Macrogen.
“Macrogen has received both CLIA and CAP accreditations for both of our clinical laboratories in Korea, as well as for the Macrogen clinical laboratory in the US; our plan is to pursue CLIA and CAP accreditations for all the Macrogen laboratories located throughout the world in Japan, Europe, Singapore, and elsewhere,” he added.
Since its registration as a genetic testing institution in 2005, Macrogen has maintained top ratings in the ‘Genetic Testing Accuracy Evaluation’ conducted by the Korean Institute of Genetic Testing Evaluation. Also, Macrogen received the ‘NGS Clinical Laboratory Certification’ from Korea’s Ministry of Food and Drug Safety in April of last year. The certification recognizes the superior quality control systems operated in Macrogen’s clinical laboratories. Macrogen has consistently proven its competencies in the field of clinical diagnostics using NGS technology, receiving CAP accreditation for its laboratories in Seoul headquarters and Bundang Precision Medicine Center.
About CLIA (Clinical Laboratory Improvement Amendments)
The CLIA regulations establish quality standards for laboratory testing performed on specimens from humans for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The certification is based on legislation passed in 1988 in the United States, and is operated and managed by the Centers for Medicare & Medicaid Services (CMS), a governing body established under the United States Department of Health and Human Services (HHS). All clinical laboratories must be properly certified to receive it in order to test patient specimens. And, when human specimens collected in the United States are tested in foreign laboratories outside the United States, the foreign laboratory performing the testing is also required to have CLIA certification. As the United States is the leading country in clinical genomic testing, the CLIA is recognized worldwide as an international certification standard.
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