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BeyondDx

  • We create New Paradigm for conquering Cancer

  • We are empowering lives providing deeper intricacies of diseases

  • Unlocking the power of precision medicine through comprehensive cancer profiling

About BeyondDx

BeyondDx is a precision medical company established in August 2023
with the goal of "Comprehensive Cancer Profiling with One Blood."

Our commitment to precision medicine goes beyond conventional approaches.
With UNIQUE iDXGate Solution, we unlock a wealth of invaluable insights,
enabling clinicians to delve deeper into the intricacies of each patient's condition.

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Our Strategy

We understand that each patient's journey with cancer is unique. That's why we have developed the groundbreaking iDXGate Solution,
a revolutionary technology that enables accurate analysis of various disease-related factors within a single blood sample.
By harnessing the power of this innovative solution, we empower clinicians to make well-informed decisions and provide patient-specific treatment plans.

Core Technology

iDXGate: UNIQUE BeyondDx Solution; Liquid biopsy-based multi-integrated analysis system

Pipeline

We are accelerating the development of innovative companion diagnostics to provide valuable insights to clinicians with our own platform technology.

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Biopharma Service

We collaborate closely with clinicians, researchers, and experts in the field to push the boundaries of what is possible.
We are helping pharmaceutical companies’ breakthrough for cancer therapeutics.

News Room

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News

BeyondDX Acquires International Standard Certification for \'ISO13485\' in Development of Multi-Integrated Analysis Solutions

https://www.thebionews.net/news/articleView.html?idxno=8225  BeyondDX Acquires International Standard Certification for \'ISO13485\' in Development of Multi-Integrated Analysis Solutions- In vitro diagnostic medical device research and development, manufacturing and quality management secured global level- \'ForeCheck LC\' to establish a bridgehead for domestic and global marketsDevelopment of Multi-integrated Analysis Solution Beyond DX (CEO Chung So-jin) announced on the 28th that it 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 the product and, in particular, meets the required holding conditions for obtaining CE-IVDR certification, a European in vitro diagnostic device certification.The scope of BeyondDX\'s ISO 13485:2016 certification includes the design, development, manufacturing, sales, and service of immunodiagnostic reagent products in the in vitro diagnostic medical device system. Through this certification, BeyondDX is fully prepared to prove its product quality level and advance into the global market.Recently, regulations on in vitro diagnostic medical devices in the European Union have been continuously strengthened. In particular, it is essential to obtain European IVDR certification, so BeyondDX plans to preemptively acquire IVDR CE certification with domestic approval of \"Forecheck LC\", a medical device for early diagnosis of lung cancer, next year to expand exports in the European market.\"Based on our excellent technology and licensing capabilities, we will take a step forward in entering not only the domestic market but also the global market,\" said Jung So-jin, CEO of BeyondDX. 

2024-08-28

News

BeyondDX selects the Ministry of SMEs and Startups Deep Tech-TIPS...Get up to 1.7 billion won in support such as R&D

https://www.yakup.com/news/index.html?mode=view&cat=12&nid=295666BeyondDX selects the Ministry of SMEs and Startups Deep Tech-TIPS...Get up to 1.7 billion won in support such as R&D  T-cell-based immune environment profiling platform \'iDX Gate IO\' spurts commercialization  BeyondDx (CEO Jung Sojin), a multi-integrated analysis solution company, announced on the 17th that it has been selected as a private investment-led technology start-up support program \"Deep-Tech TIPS\" by the Ministry of SMEs and Startups.Deep Tech Tips is part of the Super Gap Startup 1000+ Project announced by the Ministry of SMEs and Startups to select and foster promising startups in 10 new industries, and it is a project that provides up to 1.7 billion won in commercialization and overseas marketing funds, including 1.5 billion won in R&D expenses to selected companies.Beyond DX is a liquid biopsy-based multi-integrated analysis solution development and diagnostic company that was founded in August 2023 and operates a unique pipeline and specialized technology for diseases with high socio-economic needs.The difference between BeyondDx and existing liquid biopsy companies is that it uses blood as an analyte, but it combines biomarkers such as protein biomarkers, blood tumor cells, blood tumor DNA, and T cells in order to establish an optimal diagnostic system.Among the diagnostic platforms it has, this Deep Tech tip targets iDX Gate IO (TCR profiling) solution based on T cells, and quickly profiles the characteristics of T cells (neo-antigen response TCR combination) that respond to cancer environments so that they can be applied to immune-based customized treatment.The key technologies that make up iDXGate IO are the Any-Hold IO System, which captures T cells that directly react with tumor antigens, and the Immunity clustering of Lymphocyte units by TCR (iCLUST), a TCR (T-cell receptor) pattern algorithm that can determine the reactivity of T cells following treatment.An official from BeyondDx said, \"iDXGate IO core technology is designed to predict and monitor the reactivity and side effects of treatment in real time, so it will be a technology that can overcome the limitations of immune environment profiling techniques, including existing immune companion diagnostics.\"Meanwhile, since November last year, BeyondDx has been conducting collaborative research using iDXGate IO with \'Senlang Bio\', a Chinese-based cell therapy company. With the selection of Deep Tech Tips, BeyondDx plans to accelerate its global expansion.  

2024-06-17

News

BeyondDx, Certifies KGMP...Lung Cancer Screening \'ForeCheck LC\' Starts Clinical Trials

https://www.yakup.com/news/index.html?mode=view&cat=12&nid=294696  Beyond DX Certifies KGMP...Lung Cancer Screening \'ForeCheck LC\' Starts Clinical TrialsIn 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 TrillionBeyond 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 HospitalFollowing 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.\" 

2024-05-27

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