EONE-Diagnomics Genome Center (EDGC), a Kosdaq-listed genomic analysis company, said Friday that its clinical testing laboratory in Incheon had obtained the Clinical Laboratory Improvement Amendments (CLIA) certification in the U.S.

CLIA is a U.S. standard certification system that verifies the accuracy, reliability, and appropriateness of tests for laboratories that perform clinical tests to diagnose, prevent, and treat diseases.

CLIA-accredited laboratories can perform laboratory-developed tests and clinical testing services without FDA approval and provide test results to healthcare providers in the U.S.

With the acquisition of CLIA certification, EDGC will be able to directly test clinical specimens collected from the U.S. in its laboratory and provide related test results to medical institutions and hospitals in the U.S.

EDGC can now enter the U.S. diagnostic market since diagnostic tests conducted by CLIA-accredited laboratories are covered by U.S. medical insurance.

Along with CLIA certification, EDGC plans to strengthen its technological competitiveness at the international level as a precision medicine laboratory specializing in molecular diagnostics and next-generation sequencing (NGS) using liquid biopsy and various genomic tests.

EDGC was aslo accredited by the College of American Pathology (CAP) in 2018, which is the standard for clinical laboratory quality management in the U.S., and the CLIA accreditation will enable EDGC to provide high-level diagnostic testing services to medical institutions and hospitals in the U.S.

According to EDGC, the U.S. CLIA laboratory services market is estimated to be worth $100 billion in 2022 and is expected to grow at a compound annual growth rate (CAGR) of 7 percent from 2023 to 2030, reaching $180 billion by 2030.

"With this CLIA certification, we will be able to synergize our medical services and diagnostic laboratory operations in Korea and the U.S. and provide medical insurance services in the U.S.," said Lee Min-seob, CEO of EDGC. "With our excellent genomic analysis technology, we will focus on entering the U.S. market, expanding overseas markets."