IVD (In-Vitro Diagnostics)

Fujirebio Group develops break-through biomarker and diagnostic content that power critical tests across the globe’s leading diagnostic platforms. Fujirebio Group’s research infrastructure and networks in Japan, Europe, and the United States make up an integrated development system that reaches from basic research to full commercialization. The unique content resulting from this process brings unique value beyond the individual products and contributes to transforming patient journeys across the globe through life-changing diagnostics. Since Fujirebio Group developed the world’s first diagnostic test for syphilis in 1966, it has created a wide range of critical diagnostic content in the fields of infectious diseases and oncology used today in many of the world’s most trusted IVD tests. More recently, a Fujirebio Group diagnostic product that enables the detection of Alzheimer’s disease from a blood sample became the first of its kind in the world to receive approval from the FDA in the United States. This new diagnostic technology is expected to contribute to better patient care, not only by reducing the physical burden on patients but also by expanding the possibilities for early diagnosis and drug discovery and development.

Fujirebio Group developed its proprietary Lumipulse^® series of fully automated chemiluminescent enzyme immunoassay systems in 1992, followed by the ESPLINE^® series of instrument-free rapid diagnostic tests in 1997. These platforms are utilized not only by healthcare institutions but also by clinical laboratories, including the H.U. Bioness Complex. Through H.U. Group’s network, Fujirebio Group’s content and technologies support clinical practice throughout the diagnostic and treatment process.

Our innovative diagnostic technologies are delivered through global partnerships to healthcare providers around the world, helping bring advanced diagnostics closer to patients. Fujirebio Group’s CDMO (Contract Development and Manufacturing Organization) business goes beyond traditional contract manufacturing alone, flexibly adapting to the diverse business environments of each partner company and enabling collaboration at various stages, from early stage research and development through commercial manufacturing. Through this partnership-driven business model, Fujirebio Group extends the reach of its diagnostic technologies to healthcare providers and patients worldwide, including regions and clinical settings that would otherwise be beyond its direct reach. As a biomarker and diagnostic content provider, Fujirebio Group contributes to expanding access to essential testing by providing the core technologies and expertise that power diagnostic solutions worldwide.

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.