• Chances are you already know our pioneering history

    If you’re an IVD laboratory professional, chances are that our paths have already crossed.

    Since our foundation in 1950 in Japan we have acquired a number of best-in-class IVD companies (e.g. Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010), bolstering our capacity to conceive, develop, produce and deliver products of the highest quality across the world.

    Today, we are part of Miraca Group, a global Japanese healthcare player that favors cross-group R&D synergies and expertise in clinical laboratory testing (SRL), IVD testing solutions (Fujirebio) and other specialized healthcare related activities.

    As part of Miraca Group we therefore have the capacity to truly understand patient needs and we collaborate closely with clinicians and laboratorians worldwide to develop innovative IVD testing solutions for today and tomorrow.

  • Key milestones that have made Fujirebio

    1950

    Fujirebio is founded in Tokyo, Japan under the initial name Fujizoki Pharmaceutical, Co., Inc.

    1966

    Fujirebio launches HA Ag (TPHA), the world’s first hemagglutination test for syphilis.

    1978

    Fujirebio launches the syphilis SERODIA®-TP•PA test kit, destined to become a gold standard in the IVD market.

    1992

    Launch in Japan of LUMIPULSE® 1200, the first automated chemiluminescent enzyme immunoassay (CLEIA) instrument.

    1992

    Fujirebio launches its first specialized manual infectious disease tests on the INNO-LiPA®, INNO-LIA® and INNOTEST® platforms.

    1995

    The INNOTEST® hTAU Ag kit is launched and becomes the world’s first commercialized biomarker for early detection of Alzheimer’s Disease.

    1998

    Fujirebio acquires Centocor Diagnostics (USA), a pioneer in oncology testing and developer of CA125II, CA19-9 and CA15-3.

    2006

    Fujirebio acquires CanAg Diagnostics AB (Sweden), a world leader in oncology biomarker development.

    2010

    Fujirebio acquires Innogenetics NV (Belgium), a world leader in specialty molecular and immunoassay testing.

    2011

    Launch in Asia and Europe of the LUMIPULSE® G1200, a mid-sized, cartridge-based instrument for fully automated chemiluminescent enzyme immunoassay (CLEIA) testing.

    2014

    Fujirebio launches the LUMIPULSE® G600II, a compact and cartridge-based chemiluminescent enzyme immunoassay (CLEIA) testing benchtop analyzer, in European and Asian markets.

    2015

    Fujirebio launches the TENDIGO™, a cost-effective strip-processor for low throughput INNO-LIA® and INNO-LiPA® assay automation.

    2015

    Fujirebio launches the LUMIPULSE® L2400, a high-volume instrument using bottle-type reagents, in Japan.

    2016

    The LUMIPULSE® G1200, our mid-sized, cartridge-based instrument for fully automated chemiluminescent enzyme immunoassay (CLEIA) testing, is launched in the USA.

  • Download our corporate leaflet

    Our corporate leaflet regroups the full story about Fujirebio. Download a copy here.

    Download 

  • A corporate DNA rooted in a culture for excellence

    Since we launched our first IVD test kit in 1966 our products have consistently been recognized by the market for their excellence.

    We have carried out a number of successful acquisitions of best-in-class IVD companies over the years (e.g. Centocor Diagnostics in 1998, CanAg Diagnostics in 2006 and Innogenetics in 2010).

    This has further reinforced the know-how in our group and bolstered our capacity to innovate, develop, produce and deliver products of only the highest quality.

  • 25 years of automated CLEIA testing expertise

    In 1992, we launched one of the world's first fully automated chemiluminescent enzyme immunoassay (CLEIA) instruments - the very first LUMIPULSE - in Japan.

    Today, we are the second largest immunoassay instrument supplier on the Japanese market.

    Building on our long history, we recently opened a new chapter by bringing our state-of-the-art CLEIA instrument to the Asian, European and US markets.

  • World-leading strip-based diagnostics

    For decades, we have been pioneering molecular diagnostics and multiparameter immunoassay testing with our INNO-LiPA and INNO-LIA assays. 

    Today, we are a worldwide market leader in the field of strip-based assays and automation.

  • Download our corporate leaflet

    Our corporate leaflet regroups the full story about Fujirebio. Download a copy here.

    Download 

  • From specialized testing to fully automated routine solutions

    Our IVD product lines span the range from specialized manual and automated testing to fully automated routine testing solutions.

    We provide gold standard assays in the fields of neurodegeneration, oncology and syphilis testing and we continue to offer both novel and routine biomarkers that cover a wide variety of other disease states.

  • Original developers and gold standard manufacturers of oncology assays

    For the past 30 years, we have been developing and manufacturing oncology antigens, antibodies and assays for leading companies in the diagnostics industry.

    In fact, we are the original developers of market-defining oncology assays such as CA125II, CA19-9, CA15-3 and HE4.

    We are recognized today as a worldwide market leader, and gold standard supplier of oncology and other immunoassays - be they in our own formats, or those of other IVD leaders.

  • Pioneers and market leaders in neurodegeneration testing

    In 1995, we were the first to launch a biomarker for early detection of the plaques associated with Alzheimer's Disease.

    We have since collaborated closely with the scientific community to product several best-in-class biomarkers for neurodegeneration testing.

    In 2018, we were the first to launch the four most important neurodegeneration parameters on a fully automated CLEIA platform.

  • Download our corporate leaflet

    Our corporate leaflet regroups the full story about Fujirebio. Download a copy here.

    Download 

  • Global partner of choice

    Today, we sell products in more than 100 countries worldwide.

    We have offices in the United States, Latin America, Europe and Asia, and are supported by an international distribution network and leading OEMs.

    Our proven commitment to manufacturing quality has earned us a strong reputation with our direct customers, and global partners at leading diagnostic companies.

    Fujirebio group companies are certified as compliant with ISO 13485, ISO 9001, EN46001 and ISO 14001.*

    * Please visit www.fujirebio.com for the status of compliant certifications of each company.

  • Pioneering the future of Healthcare

    We are part of Miraca Group, a global Japanese healthcare player that favors cross-group R&D synergies and expertise in clinical laboratory testing (SRL), IVD testing solutions (Fujirebio) and other specialized healthcare related activities.

    The insights and know-how that our global teams of experts bring to each stage of development of a new quality biomarker or system - from concept through design to sales and service - will keep our customers at the forefront of early diagnostics and state-of-the-art healthcare solutions.

  • Fujirebio group companies

  • Visit our corporate website for full contact details

  • For more information about Miraca Holdings