https://www.yakup.com/news/index.html?mode=view&cat=12&nid=294696 

Beyond DX Certifies KGMP...Lung Cancer Screening 'ForeCheck LC' Starts Clinical Trials
In the second half of this year, clinical trials for approval at Seoul National University Hospital in Bundang began
'Forecheck LC' Challenges Global Lung Cancer Screening Market at KRW 64 Trillion

Beyond DX (CEO Jeong So-jin), a multi-integrated analysis solution company, announced that it will complete the manufacturing and quality control standards (GMP) certification of in vitro diagnostic medical devices (grade 3) for clinical performance tests of ForeCheck LC for lung cancer screening and submit a clinical performance test plan in June. Once the clinical plan is approved, it plans to start clinical trials in the second half of the year at Seoul National University Bundang Hospital

Following its export license in March, ForeCheck LC received GMP-compliant certification on the 17th, and was recognized by the Ministry of Food and Drug Safety for the stability of the production quality system of the medical device.

Beyond DX is developing and producing its own diagnostic kits for diseases with high social and economic unmet needs based on its multi-integrated analysis solution platform.

With the completion of the KGMP certification, the requirement to conduct a clinical performance test of ForeCheck LC for lung cancer screening in earnest will be met, and the clinical performance will be confirmed at Seoul National University Hospital (a team of thoracic surgery tidal technicians) in Bundang, and domestic approval will be applied for next year.

An official from Beyond DX said, "Lung cancer is a disease with a higher survival rate as it is diagnosed early, and the government is currently adopting a government-led lung cancer screening policy centered on advanced countries, which is expected to form a global market worth 64 trillion won by 2030. We expect this KGMP certification and clinical performance test to serve as a bridgehead for entry into overseas markets as well as domestic approval."