Fujirebio Diagnostics, Inc.

Fujirebio Holdings, Inc. is a subsidiary of H.U. Group Holdings Inc. that specializes in in vitro diagnostics (IVD) biomarker innovation and Contract Development & Manufacturing Organization (CDMO) services. The company drives the biomarker-to-IVD journey through research, clinical validation, and manufacturing partnerships, with a focus on transformative diagnostic solutions across multiple disease areas. Fujirebio's core offering includes the Lumipulse® platform, a fully automated immunoassay system for clinical laboratory testing, alongside manual and semi-automated assay kits (INNO-LIA®, INNO-LiPA®, INNOTEST®, CanAg®). The company manufactures diagnostic instruments, assay kits, software (LIRAS®), quality controls, and raw materials (antibodies and antigens). Primary clinical specialties include neurodegeneration (Alzheimer's disease, multiple sclerosis, Parkinson's disease, ALS), with blood-based biomarkers for amyloid and phosphorylated tau; infectious diseases (HPV genotyping, HPV screening); autoimmune disorders; cardiac markers; tumor markers; fertility and endocrinology; diabetes; and bone metabolism. Recent FDA clearances include blood-based Alzheimer's disease diagnostic tests. The company maintains regulatory credentials including FDA 510(k) clearances and CE marking. Fujirebio operates globally with CDMO partnerships, providing diagnostic raw materials, reagents, and full development and manufacturing services to technology partners and clinical laboratories.