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Profile
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Delegates :
Hirokazu Sugihara |
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Incorporated :
January 25 , 2018 |
Paid in Capital :
30 Million yen |
Employees :
21 人 |
Address :
6-1 Kishibe Shimmachi, Suita City, Osaka, 564-8565 OpenInnovationLab.NationalCerebralandCardiovascularCenter#30602 OSAKA
〒564-8565
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TEL/FAX :
06-6391-5501 / 06-6391-5502 |
URL：
https://immunosens.com/en/ |
Attachment :
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Mission/Background :
IMMUNOSENS holds licenses for in vitro diagnostic pharmaceuticals and Type 3 medical devices. It developed GLEIA, a proprietary immunoassay for highly sensitive, rapid testing. Its compact, disposable sensors enable precise measurements with small volume in about 10 min. In 2023, it raised 600 million yen in Series B-2 funding to expand applications, focusing on cardiovascular diagnostics. The company aims to make medical-grade rapid testing accessible anytime, anywhere, improving global healthcare. |
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Technology & Business
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The company's unique GLEIA technology stands out for enabling a palm-sized, world-class smallest quantitative immunoassay device while maintaining the same sensitivity as conventional optical immunoassays.
This breakthrough has significantly reduced the cost of measurement devices from 5 million to 10 million yen to an affordable 200,000 to 20,000 yen, making them accessible not only in medical facilities but also for personal healthcare use at home.
Its key differentiators are affordability, ultra-compact size, and rapid testing.
※ GLEIA: Gold Linked Electrochemical Immuno Assay (Electrochemical Immunoassay Method)
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Products & Service
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Products & Service Name
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Stage
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Outline
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Milestone
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GLEIA Check D-dimer
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Discovery
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D-dimer is a key biomarker for screening and ruling out deep vein thrombosis (DVT) and pulmonary thromboembolism (PE).
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February 2025: Class II in vitro diagnostic drug certified (No. 307AAEZX00015000); launch preparations underway.
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GLEIA Check Reader
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Discovery
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Uses GLEIA technology for precise D-dimer measurement. Provides fast results with a compact, lightweight POCT device.
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February 2025: Class I in vitro diagnostic device notified (No. 27B3X00339000001); launch preparations underway.
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Highlights
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On February 27, 2025, GLEIA Check D-dimer, which uses our proprietary technology GLEIA (Gold-linked Electrochemical Immunoassay), was approved for manufacturing and sales as a Class II in vitro diagnostic drug. In addition, we underwent a QMS compliance survey regarding manufacturing and quality control, and our compliance with the standards as a manufacturer and distributor of in vitro diagnostic drugs was confirmed (No. AA2700000600100000).
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Alliance strategy
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Our proprietary GLEIA method is a platform technology supporting over 200 immunoassays. We collaborate with partners to expand its applications beyond medical care, including stress and immunity management, athlete muscle fatigue monitoring, animal healthcare, emergency care, and disaster sites. In medical care, we focus on cardiovascular fields, particularly heart failure. We seek alliance partners for joint ventures and further development.
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