IMMUNOSENS Co., Ltd.

IMMUNOSENS Co., Ltd. is a medtech and in vitro diagnostics company spun out of the University of Osaka in 2018. We are developing GLEIA (Gold-Linked Electrochemical Immunoassay), a proprietary platform designed to bring high-sensitivity, quantitative biomarker testing closer to patients.

GLEIA combines gold-nanoparticle-labeled immunoassays with electrochemical detection. Following the immunoreaction, the gold label is converted into an electrical signal and quantified. The Bluetooth-enabled reader fits in the palm of a hand and is roughly the size of a compact power bank. Used with a disposable sensor, it generates quantitative results in 5–10 minutes. Depending on the target biomarker, GLEIA can achieve analytical sensitivity down to approximately 1 pg/mL, comparable to that of large clinical laboratory analyzers. To illustrate this scale, 1 pg/mL corresponds roughly to one 2–3 mg crystal of coarse sugar dispersed throughout a 50-meter competition swimming pool. At approximately one-thousandth the price of a large clinical laboratory analyzer, the reader makes high-performance testing economically accessible to small clinics and is designed to support future in-home use. Together, its compact size, high sensitivity, rapid measurement and affordability open the way to decentralized testing and, ultimately, physician-supervised self-monitoring at home.

Our primary medical focus is heart failure, a major global cause of hospitalization, mortality and healthcare expenditure. NT-proBNP is a key biomarker for diagnosis and disease management, but centralized laboratory testing can make frequent monitoring difficult. IMMUNOSENS has obtained Japanese regulatory Class II certification for its NT-proBNP and D-dimer in vitro diagnostic assays and has completed the required Class I medical device notification for its compact reader. By enabling rapid NT-proBNP measurement near the patient, GLEIA is intended to support earlier recognition of worsening heart failure, timely clinical decisions and more effective post-discharge and chronic-care pathways.

Beyond cardiac care, our development pipeline includes CRP, myoglobin, estradiol and salivary sIgA, as well as biomarkers for veterinary medicine. This modular pipeline supports expansion into women’s health, daily condition monitoring, sports and animal health. We are also developing complementary measurements for creatinine and serum electrolytes to increase the clinical value of decentralized chronic-disease monitoring.

Our business model combines compact readers with recurring sales of single-use sensors, supported by B2B partnerships for assay development, manufacturing, distribution and digital integration. Working with medical institutions and industrial partners, we are advancing clinical validation, scalable production and market introduction in Japan, followed by international expansion across Australia, Singapore, Europe, the United States and other Asia-Pacific markets.

IMMUNOSENS aims to transform biomarker testing from episodic, centralized measurement into accessible, connected and longitudinal monitoring. By combining the analytical sensitivity of a large laboratory system with a palm-sized reader at a fraction of the cost, we seek to help healthcare providers move from reactive care toward earlier, data-driven intervention and to establish a globally scalable platform for decentralized diagnostics.