In Vitro Diagnostics
A leading company in immunoserologic diagnostics
Fujirebio successfully commercialized the world’s first serologic test reagent for syphilis and released the Treponema pallidum hemagglutination (TPHA) test kit. Since then, Fujirebio has been offering a broad array of products, including test reagents and testing devices mainly in the fields of infectious and oncological diseases to medical institutions and commercial laboratories across the country.
As a leader in immunoserology, Fujirebio remains constantly committed to the research and development needed to improve reliability and accuracy of testing, aiming to achieve diversification and provide faster testing.
A broad lineup of products, principally for diagnostics of infectious diseases and cancer
Fujirebio released the LUMIPULSE® 1200 automated chemiluminescent enzyme immunoassay (CLEIA) analyzer in 1992. Since then, the analyzer has been remodeled and extended to respond to customer requests. Now it diagnoses not only infectious diseases but also tumor markers and endocrine disorders attributable to lifestyle-related and other diseases.
At present, three different models with different processing capacities are available in Japan: the LUMIPULSE® Presto™ II, the LUMIPULSE® G1200, and the LUMIPULSE® S. In 2007, the Japanese Red Cross Society adopted the CL4800 testing system developed based on the LUMIPULSE® series as a next-generation diagnostic system for donated blood.
In answer to the diversification of lifestyles and social needs, Fujirebio provides highly unique products. They include a lifestyle-related disease test, a quick influenza test kit that produces rapid results with simple operation, a colorectal cancer diagnostic system, and a nucleic acid test system.
Footsteps of a global life science company
Fujirebio began exporting clinical diagnostic reagents to overseas markets in 1970. It acquired the diagnostics division of US-based Centocor Diagnostics, Inc. to establish Fujirebio Diagnostics Inc. as a production base in the United States. It then launched new production and sales sites in Europe and Asia to steadily expand its business territory. In 2010, Fujirebio also acquired a Belgium-based diagnostic company, Innogenetics N.V. At present, Fujirebio supplies diagnostic reagents to more than 100 countries.
To establish world-class quality assurance, Fujirebio has been certified with the international quality assurance standards ISO 9001 and ISO 13485 for all products and business establishments. With respect to environmental management, it has obtained the ISO 14001 international standard certification for all facilities, part of its commitment for developing environmentally considerate products.
