Fujirebio Diagnostics, Inc.

Fujirebio Diagnostics, Inc. is the U.S. subsidiary of Fujirebio Holdings, Inc., a Japanese multinational in vitro diagnostics (IVD) company founded in Tokyo in 1950. The U.S. headquarters for Fujirebio Diagnostics, Inc. are in Malvern, Pennsylvania. Fujirebio Holdings, Inc. is a consolidated subsidiary of H.U. Group Holdings, Inc., which is listed on the Tokyo Stock Exchange (TYO: 4544). Fujirebio Diagnostics, Inc. has approximately 316 employees as of December 2025. Fujirebio (the parent company) employs more than 1,400 people globally and has an estimated annual revenue of nearly $59 million.

Fujirebio Diagnostics, Inc. develops, manufactures, and markets in vitro diagnostic testing solutions. Their product lines include automated immunoassay analyzers and kits, as well as manual and semi-automated assay kits. The company focuses on developing new technologies and biomarkers for a range of conditions, including neurodegenerative diseases like Alzheimer's disease, oncology, and infectious diseases. Notable products include their Lumipulse® series of automated immunoassays, which includes the first FDA-cleared blood-based IVD test to aid in identifying amyloid pathology associated with Alzheimer's disease.

Fujirebio Diagnostics, Inc. appears in the provided data as a plaintiff in one case, Fujirebio Diagnostics, Inc. v. Quanterix Corp., filed in the Patent Trial and Appeal Board (PTAB) in 2025. This indicates an active posture in asserting its intellectual property. The case also involves Fujirebio Europe N.V. as a counter-defendant.

The company has a history of strategic partnerships to advance biomarker development, particularly in Alzheimer's disease. For instance, Fujirebio Diagnostics, Inc. partnered with AriBio Co., Ltd. to access clinical samples and data from AriBio's Phase 3 Alzheimer's disease study. This collaboration highlights Fujirebio Diagnostics' commitment to innovation in neurodegenerative disease diagnostics.