Notice

Obtaining In-vitro diagnostic medical device manufacturing and quality control standards compliance

BeyondDX, a multi-integrated analysis solution development company, will enter the cancer screening market in earnest. It has been recognized that the GMP manufacturing plant at 60 Haan-ro, Gwangmyeong-si, Gyeonggi-do, 1506 C-dong, 1507 meets the in vitro diagnostic medical device manufacturing and quality standards (GMP) after being reviewed by the Korea Institute of Industrial Technology (KTL) and the Ministry of Food and Drug Safety.In addition to the ISO 13485:2016 international standards acquired in August, we have secured facilities in accordance with the Enforcement Rules of the In vitro Diagnostic Medical Device Act and production infrastructure that meets domestic and international standards of manufacturing and quality management systems.BeyondDX will show examples of establishing commercialization partnerships with ForeCheck LC\'s domestic and foreign licenses based on proven production/development infrastructure, and will work hard to expand to global markets such as Europe and the United States.     

2024-12-09

Notice

[Paper Publication] Mutational differences between primary cancer tissue and circulating tumor cells in early-stage non-small cell lung cancer.

 The key role of circulating tumor cells in distant metastasis from the early stage of cancer has been confirmed by applying our iDXGate TO platform to early lung cancer. Compared to primary cancer, we have identified distinct mutation patterns related to distant metastasis and will be a key indicator for pre- and post-treatment metastasis monitoring.  https://tlcr.amegroups.org/article/view/92819/html 

2024-12-09

Notice

BeyondDx Obtains ISO13485:2016, International Medical device Quality Management System certification

 BeyondDX has first certified ISO 13485:2016 (Medical devices-Quality Management Systems for Regulatory Purpose), an international medical device quality management system certification.   ISO 13485:2016 certification is an international standard certification that ensures that developers of in vitro diagnostic medical device manufacturing comply with the quality, safety and regulatory requirements of their products, and in particular, is required for obtaining CE-IVDR certification, a European in vitro diagnostic device certification.   Through this certification, we are fully prepared to prove the quality of our products and enter the global market. 

2024-08-28

News

BeyondDx to Present Clinical Results of ‘ForeCheck LC’ for Early Lung Cancer Detection at ASCO 2025

https://www.biotimes.co.kr/news/articleView.html?idxno=20498BeyondDx to Present Clinical Results of ‘ForeCheck LC’ for Early Lung Cancer Detection at ASCO 2025Blood biomarker analysis completed within just 150 minutes, offering speed and efficiency Demonstrated sensitivity of 81.9% and specificity of 90.1% in early-stage (Stage 1/2) lung cancer[BioTimes] BeyondDx, a company specializing in multi-integrated analysis solutions, announced on March 27 that it will present clinical study results of its early lung cancer diagnostic in-vitro device, ‘ForeCheck LC’, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago this May.‘ForeCheck LC’ is a blood-based diagnostic device leveraging BeyondDx’s proprietary multi-integrated analysis solution for early lung cancer detection. The device provides optimal diagnostic insights through a simple blood test and employs specific multi-biomarkers and machine learning algorithms to detect lung cancer, even in hard-to-identify Stage 1 and 2 cases. Notably, it can complete blood biomarker analysis and deliver results within just 150 minutes, emphasizing speed and efficiency. At ASCO 2025, BeyondDx will unveil key findings from a clinical study conducted in collaboration with Professor Seok Ki Cho’s team at Seoul National University Bundang Hospital’s Department of Thoracic Surgery. The study evaluated the performance of ‘ForeCheck LC’ in a cohort of approximately 1,800 lung cancer patients (Stages 1–4). The results confirmed a sensitivity of 81.9% and specificity of 90.1% for early-stage (Stage 1/2) lung cancer, underscoring its potential as a blood-based alternative to low-dose computed tomography (LDCT), which has certain limitations. A BeyondDx representative stated, “ForeCheck LC is an innovative early lung cancer diagnostic solution that ensures high compliance among high-risk, asymptomatic individuals. With its rapid, convenient, and cost-effective approach, it presents a promising alternative to conventional imaging tests.” The company plans to initiate pivotal clinical trials in mid-2025 for regulatory approval in South Korea and is actively engaging with potential partners to accelerate market entry.  [BioTimes | Reporter: Jisoo Kim] news@biotimes.co.kr

2025-03-27

News

BeyondDx Signs MOU with Luye Diagnostics for Joint Clinical Research, Marking First Step into the Chinese Market

https://www.thebionews.net/news/articleView.html?idxno=13113BeyondDx Signs MOU with Luye Diagnostics for Joint Clinical Research, Marking First Step into the Chinese MarketBy Kang In-hyo, The Bio | Published: 2025.02.27 06:10 | Updated: 2025.02.27 07:52Collaboration on clinical research for early lung cancer diagnosis and major depressive disorder (MDD) diagnostic pipelines in ChinaClinical research and development of \"ForeCheck LC\" for lung cancer and \"ForeCheck MDD\" for depression in the Chinese market  BeyondDx, a developer of multi-integrated analysis solutions, announced on the 27th that it signed a memorandum of understanding (MOU) with Beijing-based Luye Diagnostics LLC on February 7 for joint clinical research. Under the agreement, the two companies will collaborate on local clinical research and commercialization efforts for BeyondDx’s early lung cancer diagnostic pipeline, ForeCheck LC, and its major depressive disorder diagnostic pipeline, ForeCheck MDD, in China.Luye Diagnostics is a subsidiary of Luye Pharma Group Ltd., a leading global company specializing in oncology and neurology, headquartered in China. The company operates branches in China, Singapore, and the United States, offering genetic diagnostic reagents, companion diagnostics for cancer, and related services. Since 2021, Luye Diagnostics has expanded its business into mental health through Mindfront Health, a subsidiary of Luye Pharma Group, providing comprehensive services from diagnosis to treatment. BeyondDx expects significant synergies with its leading diagnostic pipelines through this partnership. China is actively investing in healthcare infrastructure under its government-led policy, \"Healthy China 2030 (健康中国 2030)\", which includes detailed management guidelines for chronic diseases such as cancer and mental illnesses. The initiative aims to enhance early diagnosis and treatment capabilities. Lung cancer is a major health concern in China, with approximately 1.06 million new cases annually and one of the highest mortality rates globally, driving an urgent need for early detection solutions. Depression is also a growing public health issue, exacerbated by psychological and social factors. Notably, 70% of suicides in China are linked to depression, yet the country faces a severe shortage of hospitals and medical professionals specializing in mental health. This highlights the urgent need for a robust early diagnosis and management system. Jung So-jin, CEO of BeyondDx, stated, “Through our partnership with Luye Diagnostics, we aim to accelerate clinical trials, regulatory approvals, and commercialization in China, laying the groundwork for our global market expansion.”

2025-02-27

News

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

 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 国: 癌症防治 动实施 动, 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.\"   

2024-12-10