GC Cell Obtains International Standard 'ISO 15189 Accreditation'... Strengthening Clinical Specimen Analysis Capabilities

Full-scale Overseas Expansion Planned

[Asia Economy, reporter Kim Jihee] GC Labcell’s clinical specimen analysis service subsidiary, GC Cell, has obtained international standard ‘ISO 15189 accreditation’.

On March 11, GC Cell announced that it had received ‘internationally accredited medical testing institution ISO 15189 accreditation’ from the Korea Laboratory Accreditation Scheme (KOLAS), which is under the National Institute of Technology and Standards of the Ministry of Trade, Industry and Energy, for its diagnostic laboratory medicine and systems divisions. ISO 15189, established by the International Organization for Standardization (ISO), is an international standard that certifies that various clinical tests conducted by medical testing institutions meet technical requirements and reliability standards.

GC Cell was established in 2019 as a joint venture between GC Labcell and C&R Research, a leading domestic contract research organization (CRO). It is the first central lab in Korea to provide clinical specimen analysis services throughout the entire cycle, from Phase 1 clinical trials to approval clinical trials. A central lab refers to an institution that collects specimens obtained before and after clinical trials from multiple hospitals and analyzes them in a single laboratory to ensure accurate clinical trial results.

With the acquisition of ISO 15189, GC Cell plans to strengthen its clinical trial specimen analysis capabilities and actively pursue overseas expansion.

Yang Songhyun, CEO of GC Cell, stated, “By enhancing our core competencies in clinical specimen analysis, we will accelerate our efforts to target the increasingly specialized market,” adding, “We also plan to further materialize our entry into global markets, including China, in the future.”

This content was produced with the assistance of AI translation services.