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BeyondDx Obtains Export Permit for Early Lung Cancer Detection Kit 'Forecheck LC'

'ForeCheck LC' Challenges the 64 Trillion Won Global Lung Cancer Screening Market with Groundbreaking Performance

BeyondDx, a company specializing in multi-omics analysis solutions (CEO: Jung Sojin), announced on the 26th that it has obtained a Grade 3 medical device manufacturing license for the in vitro diagnostic medical device 'Forecheck LC' for early diagnosis of lung cancer from the Ministry of Food and Drug Safety.

Forecheck LC utilizes BeyondDx's core technology, the 'multi-omics analysis solution', to provide optimal diagnostic information with a single test. According to BeyondDx, it can produce results within approximately 150 minutes from blood collection to biomarker measurement and analysis, demonstrating superior performance compared to standard diagnostics. In particular, it achieved a sensitivity of 81.9% and a specificity of 90.1% in internal exploratory clinical trials, shortening the analysis time and enhancing competitive pricing compared to competitor products.

According to the analysis by the Data Analysis Division of the Korea Agency for Science and Technology (ASTI), the global market size of lung cancer therapeutics is expected to expand from approximately $23.404 billion (31 trillion won) in 2020 to approximately $48.276 billion (64 trillion won) in 2029, with an average annual growth rate of 13%. Through this export permit, BeyondDx has laid the groundwork for entering overseas markets.

With the recent establishment of the 'Digital Healthcare Products Act' by the Ministry of Food and Drug Safety, the domestic medical device industry has created a foundation for further growth.

A BeyondDx official stated, "Lung cancer is a disease with increased survival rates depending on the possibility of early diagnosis. Currently, government-led lung cancer screening policies are being adopted mainly in advanced countries." They added, "Through this export permit, we are formulating strategies for entering markets such as Europe and the United States, starting with China, where there is the greatest unmet demand for this product."

Meanwhile, BeyondDx is preparing for clinical trials of the product for domestic approval and launch in the latter half of this year.