Fujirebio is a Japanese multinational in vitro diagnostics (IVD) company, founded in 1950 and headquartered in Tokyo, Japan. The company develops, manufactures, and markets IVD testing products â including reagents, instruments, and software â for clinical diagnostics and research use. Fujirebio operates offices in Asia, Europe, and the United States, and maintains a broad international distribution network, with manufacturing facilities in Japan, Europe, and the United States. The company employs more than 1,400 people globally.
Fujirebio operates an open business model in which it develops novel biomarkers and diagnostic content, validates them using its own fully-automated Lumipulse<sup>î</sup> chemiluminescent enzyme immunoassay (CLEIA) platform, and distributes them globally through partnerships and a Contract Development and Manufacturing Organization (CDMO) model â providing development, manufacturing, and regulatory services to third-party diagnostic companies.
The companyâÂÂs principal areas of expertise include oncology, infectious diseases, and neurological disorders. In May 2025, Fujirebio received FDA 510(k) clearance for the Lumipulseî G pTau 217/ò-Amyloid 1-42 Plasma Ratio test, the first FDA-cleared blood-based IVD test to aid in identifying amyloid pathology associated with AlzheimerâÂÂs disease. In 2022, Fujirebio acquired ADx NeuroSciences, a Belgian biotech company specializing in neurological biomarker research, for â¬40 million.
Fujirebio is a consolidated subsidiary of H.U. Group Holdings, Inc. (Tokyo Stock Exchange: TYO 4544), which also includes SRL Inc., the largest commercial clinical laboratory in Japan.
Fujirebio was founded in Tokyo, Japan in 1950 under the name Fujizoki Pharmaceutical, Co., Inc. In its early days the company developed and manufactured pharmaceutical products.
The company's first IVD test was launched in 1966, a TPHA kit for syphilis testing. In 1983 the company changed name to Fujirebio Inc. Between 1998 and 2010 Fujirebio acquired several specialized IVD companies, notably Centocor Diagnostics (1998), CanAg Diagnostics (2006) and Innogenetics (2010). In 2005, Fujirebio Inc. was integrated together with the commercial laboratories SRL, Inc. ("Special Reference Laboratories", established in 1970) under the holding company Miraca Holdings Inc. (which was renamed to H.U. Group Holdings, Inc. in 2020).
The current company structure, Fujirebio Holdings, Inc. was created in 2017 as a parent company of Fujirebio Inc., Fujirebio Diagnostics, Inc., Fujirebio Europe N.V. and other Fujirebio group companies. In 2022, Fujirebio acquired respectively the companies ADx NeuroSciences and Fluxus, Inc. In 2025, Fujirebio acquired Plasma Services Group, Inc.