EDGC (Eone Diagnomics Genome Center) said has successfully completed its acquisition of GDXLab, a CLIA (Clinical Laboratory Improvement Amendments) certified lab located in the southern part of Denver, Colorado.

The company believes that the acquisition is set to amplify EDGC's drive into the North American market for diverse molecular diagnostics and genomic services.

Notably, GDXLab holds a MOLDX approval in the NOVITAS jurisdiction, enabling them to make medical claims under the U.S public health system, Medicare.

This allows them to execute various molecular diagnostic tests based on the next-generation sequencing (NGS) and directly bill for these services.

CLIA certification, awarded by the U.S. Centers for Medicare & Medicaid Services (CMS), signifies a laboratory's capability to perform diagnostic testing intended for disease diagnosis, prevention, and treatment. GDXLab also recently passed a stringent assessment by COLA (Commission on Office Laboratory Accreditation), another laboratory accreditation recognized in the U.S.

Through the newly acquired CLIA lab, EDGC is currently in the process signing an agreement to supply its early cancer detection service, OncoCatch, to multiple CLIA labs, including prestigious institutions like the Saint John’s Cancer Institute and the City of Hope National Medical Center.

Collaborations are also underway with several cancer specialist hospitals to promote the joint business of Epicatch, which offers diagnosis capabilities for up to 10 major cancers.

Driven by an aging population, rising medical demands, the increase in chronic diseases, and the surging demand for personalized medicine and precision diagnostics, the CLIA lab market is witnessing substantial expansion.

Predicted to grow from $93 billion last year to $125.6 billion by 2030, particularly, the molecular diagnostics market based on NGS is garnering significant attention due to advancements in diagnostic technology and expanded insurance coverage for novel lab services.

The acquisition of GDXLab is the latest achievement in EDGC’s efforts to expand into the North American market as the company recently received export permission for OncoCatch-E, a colon cancer diagnostic kit, from the Ministry of Food and Drug Safety on Monday.

“Our OncoCatch service is gaining global recognition and continues to produce tangible results.” EDGC CEO Lee Min-seob said. “We anticipate that the acquisition on GDXLab will serve as a stepping stone, accelerating our global outreach, especially in the North American market.”