Kyeong-Sik Shin, CEO of Bioxonics
Its system can diagnose Alzheimer’s disease with over 90% accuracy based on the AUC criterion, using blood
Establishing a unique, high-sensitivity, semiconductor-based immune response analysis system
Its flagship product is a blood-based in vitro diagnostic system for Alzheimer’s dementia. “Most developed countries worldwide are facing the problem of a significant increase in dementia patients due to aging populations. In Korea, in particular, the increase is so rapid that the social costs associated with dementia, as well as the difficulties faced by individuals and families, are expected to rise substantially over the coming decades. The largest proportion of dementia cases, accounting for 75% of all patients, is Alzheimer’s dementia. Currently, the best approaches are early diagnosis and prompt management, as there is no definitive treatment for Alzheimer’s disease (AD).”
To meet this need, Bioxonics began developing a diagnostic system using KIST’s Alzheimer’s dementia diagnostic technology in 2018 through KIST’s BioStar project. The company has now developed an in vitro diagnostic system that can diagnose Alzheimer’s disease with over 90% accuracy, based on the AUC criterion, using blood samples. Bioxonics aims to obtain authorization and permission by the first half of 2026 and launch its diagnostic services and products in the second half of that year.
The company also plans to expand the range of diseases it can diagnose to include Parkinson’s disease, cardiovascular disease, diabetes, viral diseases, and more. This will provide a comprehensive diagnostic solution for adult and age-related diseases that were difficult to diagnose early using existing methods.
Bioxonics has developed a unique high-sensitivity semiconductor-based immune response analysis system to overcome existing limitations. This system consists of three core technologies.
The first is ultra-high-sensitivity semiconductor sensor technology. The most critical factor in Alzheimer’s blood diagnostics is the ability to precisely detect trace biomarker levels. Bioxonics’ sensors demonstrate sensitivity performance 100 to 1,000 times higher than existing commercial sensors. This makes it possible to find biomarker signals even when the disease is still in its early stages. Importantly, because it is based on semiconductor processes, it offers significant competitive advantages over existing technologies in terms of cost efficiency, miniaturization, and mass production.
The second is aggregated protein-based diagnostic algorithm technology. One of the key biomarkers of Alzheimer’s disease has a tendency to aggregate, and it is actually the aggregated form of this protein that is closely linked to disease progression. However, existing technologies have struggled to quantify these aggregates. Bioxonics developed an algorithm that precisely measures the ratio of aggregated to native protein, thereby enhancing diagnostic sensitivity and specificity.
The third is ultra-high-sensitivity biomarker detection technology based on nanovesicles. Bioxonics has secured technology to detect specific biomarkers on the surface of nanovesicles (e.g., exosomes) in blood with high sensitivity. This method outperforms existing approaches in terms of biomarker stability, selectivity, and sensitivity. Nanovesicles, in particular, preserve biological information derived from diseased cells, making them highly effective targets for early diagnosis.
Bioxonics’ in vitro diagnostic system targets primary healthcare institutions—such as small and medium-sized hospitals, health screening centers, and health centers—where actual diagnostics are performed as its core customer base. Since medical institutions in Korea constitute over 85% of clinic-level institutions, the company is focusing its efforts on developing this in vitro diagnostic system. Initially, the company plans to validate its product at university hospitals and screening centers before expanding to smaller hospitals, nursing facilities, and health centers. Furthermore, the company is reviewing the possibility of health insurance coverage should it enter the market for health examination services.
Regarding future plans, Shin stated, “We are aiming to receive approval for each item by the first half of next year,” adding, “We hope investment attraction proceeds smoothly so we can move forward as planned.”
Founded: November 2020
Main business: blood-based Alzheimer’s dementia in vitro diagnostic system
Achievements: Registered five patents; Filed eight patent applications; Secured six trademark rights; Registered one design right; Completed eight cumulative projects as of August 2025; Won first prize at the 2024 Korea-China-Japan Youth Innovation Cooperation Exhibition Contest in April 2024; Established a local subsidiary in China in September 2023; Received the MEDITEK Innovation Award in the Medical Devices/Diagnostic Laboratory Equipment category in 2023; Won the CES 2023 Innovation Award in January 2023; Certified as a company-affiliated research institute in January 2022; Received an excellence award at the first Hongneung Innopolis Campus GRaND-K Startup Competition in April 2021; Registered as a venture business in January 2021; Selected for the Pre-Startup Package program in 2020; Achieved top performance in project execution in 2021; Completed a Ministry of Science and ICT project (2018–2020); Selected among the top 100 outstanding social problem-solving R&D achievements in 2021
reporter jinho lee
jinho2323@hankyung.com
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