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Beyond DX Enters 'ForeCheck LC' Market for Lung Cancer Screening

2024-12-10 15:13:58

 

https://www.yakup.com/news/index.html?mode=view&cat=12&nid=303512

 

Beyond DX Enters 'ForeCheck LC' Market for Lung Cancer Screening


Establishment of global manufacturing and quality management infrastructure for in vitro diagnostic medical devices

'ForeCheck LC' clinical cruise in Korea to discuss development with local partner in China



BeyondDX (CEO Sojin Jung), a multi-integrated analysis solution developer, announced on the 9th that it will enter the cancer screening market in earnest.


Biond DX was recognized for meeting the GMP manufacturing standards for in vitro diagnostic medical device manufacturing and quality standards (GMP) after screening by the Korea Institute of Industrial Technology (KTL) and the Ministry of Food and Drug Safety for GMP manufacturing plants in Haan-ro 60, C-dong 1506, and 1507 in Gwangmyeong-si, Gyeonggi-do.


In addition to the ISO 13485:2016 international standards acquired in August, facilities under the Enforcement Rules of the In Vitro Diagnostic Medical Device Act and production infrastructure suitable for domestic and international standards of manufacturing and quality control systems have been secured.


Currently, the domestic clinical trial of 'ForeCheck LC', a lung cancer screening in vitro diagnostic medical device based on Beyond DX's multi-integrated analysis solution, is cruising, and detailed development is being discussed with local partners embodied for the entry of China, the first global target country.


According to Dr. Chen Wanqing of the Cancer Research Institute of the Academy of Chinese Medical Sciences, about 2,000 new lung cancer patients occur a day and about 1,700 die due to the aging population and severe air pollution in China. Accordingly, the Chinese government is implementing a policy to increase the five-year survival rate of cancer to 46.6% by 2030 (健康 : 癌症防治 动实 , 2023-2030). Lung cancer is one of the low-survival cancers, but early detection is of paramount importance as the five-year survival rate reaches 80%.


BeyondDX CEO Jung Sojin said, "Beyond DX will show an example of establishing a commercialization partnership with ForeCheck LC's domestic and foreign permits based on proven production and development infrastructure," adding, "We will expand to global markets such as Europe and the United States in the future."