Our Business

IVD (In-Vitro Diagnostics)

Operating under Fujirebio Holdings, subsidiaries located in Japan, the United States, and Europe go beyond company boundaries and promote the new global strategy, delivering invitro diagnostics worldwide.
The driving force behind our growth is our research and development (R&D) capabilities. By continually strengthening our R&D efforts, we strive to commercialize “only one” markers ahead of other companies. With a focus on Japan, we utilize our own platform to demonstrate the clinical value of these markers. Furthermore, through partnerships with in-vitro diagnostics companies worldwide, we utilize the CDMO (Contract Development and Manufacturing Organization) business model to expand our reach globally.

Since developing and launching a biomarker for early detection of the plaques associated with Alzheimer’s disease in 1995, we have served as a global leader in testing for neurodegenerative diseases. For over 25 years, we have continued to expand our R&D efforts and reagent lineup.
Our initiatives have been strengthened through the 2010 acquisition of Innogenetics N.V. (current Fujirebio Europe N.V.). In the field of Alzheimer’s disease, we obtained approval for a cerebrospinal fluid reagent, which is compatible with our fully automated chemiluminescent enzyme immunoassay system. Approval was obtained in Japan, the United States, and Europe, and it was successfully launched. We are also working on the development of blood-based reagents, which are experiencing a growing demand. We have already developed six markers that are available as research reagents. Additionally, we are preparing for the regulatory submission of these blood-based reagents in major countries.
In 2022, we acquired ADx NeuroSciences N.V., a Belgian biotech company that has developed biomarkers specifically for neurodegenerative diseases such as Alzheimer's. In addition to our involvement in the development of neurodegenerative diseaserelated markers beyond those for Alzheimer’s disease, we will supply key raw materials to global in-vitro diagnostics companies through a CDMO business model.

Since 1992, we have utilized our proprietary fully automated chemiluminescent enzyme immunoassay system. This platform has gained high recognition and has been supporting medical institutions and testing centers for over 30 years. In addition, in 1997, we launched a rapid diagnostics kit that does not require a special testing device. As the kit provides convenient and quick test results, it serves as a platform for testing infectious diseases such as influenza and COVID-19, and we have been expanding its reagent lineup.
In 2022, we acquired Fluxus, Inc., an innovative company located in Silicon Valley, United States. Together with the company, we have been jointly developing a diagnostic platform utilizing ultra-high sensitivity detection technology. Building upon the existing platform functions, we are developing a platform that shapes future testing.

At Fujirebio, we are committed to daily efforts to guarantee the highest possible quality for the products created as a result of development and manufacturing activities.

Acquisition date Certification Target facility
2001 2001 ISO 13485 certified Main Office,Hachioji Office(including Hachioji Plant 3), Sagamihara Plant, Tokachiobihiro Plant, Ube Plant, Asahikawa Plant,Distribution Center(Atsugi aikawa) (All 8 domestic offices)