"Challenging Early Dementia Diagnosis with a Single Drop of Blood" — BREDIS Healthcare Selected for National Brain Science Project

As the number of patients with dementia and neurodegenerative brain diseases rapidly increases, competition in early diagnosis technology is intensifying. Recently, research using blood-based biomarkers — rather than cerebrospinal fluid tests or costly imaging studies — to predict disease risk at an early stage has emerged as a key area in the global medical market. BREDIS Healthcare, a company specializing in ultrasensitive biomarker analysis, announced on the 28th that it has been selected as the lead R&D institution for the "Brain Science Leading Convergence Technology Development Program," part of the Ministry of Science and ICT's Bio & Medical Technology Development Program. Through this program, the company will receive a total of KRW 2.06 billion in R&D funding over the next three years. The project aims to develop early diagnosis technology for neurodegenerative brain diseases and advance it toward clinical application. BREDIS Healthcare will lead the research through an industry-academia-hospital consortium formed with Konkuk University's Industry-Academic Cooperation Foundation and the Department of Neurology at Hanyang University Guri Hospital. As the overall project lead, BREDIS Healthcare will be responsible for designing ultrasensitive biosensors, developing prototypes, establishing analysis protocols, and formulating a commercialization strategy. Professor Kisoo Park's research team at Konkuk University will handle the development of isothermal nucleic acid amplification-based reagent technology and core detection mechanisms, while Professor Hyukseong Kwon's research team at Hanyang University Guri Hospital will be responsible for securing clinical samples and validating clinical efficacy. A central goal of the project is the development of PLEX-STAR, a next-generation ultrasensitive analysis platform. **"Going Beyond the Limits of Digital ELISA" — Developing a Next-Generation Multiplex Platform** In the field of ultrasensitive protein analysis, SIMOA-based Digital ELISA technology is currently the most widely used approach. However, its complex fluid control requirements and enzyme-based reaction structure have been noted as limitations, making equipment operation and reproducibility difficult and driving up costs. To address these challenges, BREDIS Healthcare has developed its own digital immunoassay platform, BREDIS DIA. The technology is designed to enable highly sensitive quantitative analysis of phosphorylated tau (p-Tau), an Alzheimer's biomarker present in blood at extremely low concentrations. The company is currently pursuing domestic regulatory approval for its p-Tau testing reagent, while also advancing commercialization of BREDIS QDIA, a quantum dot cluster-based platform that enhances signal stability without relying on enzymatic reactions. PLEX-STAR, to be developed through this national project, is intended to overcome the reproducibility and automation limitations of existing digital immunoassay technology, and to be built as a multiplexing-based platform capable of simultaneously analyzing multiple biomarkers. Using this platform, BREDIS Healthcare also plans to develop an in vitro diagnostic solution based on brain-derived phosphorylated tau. The company expects that reducing the influence of signals originating from peripheral tissue will strengthen the correlation with actual brain pathology. BREDIS Healthcare operates a GCLP-based analysis environment and a GMP-compliant clean-room manufacturing infrastructure, and provides analysis services for key Alzheimer's biomarkers including p-Tau217, GFAP, and NfL. The company has also recently established a joint research center at the National University of Singapore (NUS) and is expanding clinical collaborations with global pharmaceutical companies, accelerating the build-out of its international network. "Being selected for this national project reflects recognition of the clinical potential of our ultrasensitive biomarker technology," said Hyundoo Hwang, CEO of BREDIS Healthcare. "We will continue to contribute to shifting the paradigm of dementia care toward early prediction and prevention through blood-based early diagnosis technology."