Fujirebio

Fujirebio is a Japanese multinational in vitro diagnostics (IVD) company headquartered in Tokyo. Founded in 1950 as Fujizoki Pharmaceutical Co., Inc., it initially worked in pharmaceuticals before moving into diagnostic testing. Its first IVD product, a TPHA hemagglutination kit for syphilis testing, was introduced in 1966. The company adopted the Fujirebio name in 1983 and has since developed into an international diagnostics organization with operations, subsidiaries, manufacturing capabilities, and distribution relationships spanning Japan, North America, Europe, and other Asian markets. The company develops, manufactures, and markets diagnostic reagents, automated analyzers, software, and related laboratory products. Its technology portfolio covers immunoassay, molecular and specialty diagnostic testing, blood screening, oncology, infectious diseases, and neurological disorders. Fujirebio is particularly associated with tumor-marker assays and with the Lumipulse platform, a fully automated chemiluminescent enzyme immunoassay system used for clinical laboratory testing. The company combines proprietary biomarker discovery and assay development with instrument and reagent manufacturing, regulatory support, and commercial distribution. Fujirebio describes its business model as open and partnership-oriented. In addition to selling its own branded products, it can provide development, manufacturing, regulatory, and other services to third-party diagnostic businesses through a contract development and manufacturing organization model. This gives the company a role both as a branded IVD supplier and as an infrastructure and technology partner for other healthcare companies. Its international structure has been strengthened through acquisitions, including Centocor Diagnostics in the United States, CanAg Diagnostics in Sweden, Innogenetics in Belgium, ADx NeuroSciences in Belgium, and Fluxus in the United States. A major recent area of expansion is neurological testing. Fujirebio acquired ADx NeuroSciences in 2022, adding expertise in biomarkers associated with neurodegenerative disease. In May 2025, the company received U.S. Food and Drug Administration 510(k) clearance for the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test. The clearance made the test the first FDA-cleared blood-based in vitro diagnostic test intended to aid identification of amyloid pathology associated with Alzheimer’s disease, marking an important development in the company’s neurodiagnostics strategy. Fujirebio is a consolidated subsidiary of H.U. Group Holdings, Inc., a Tokyo-listed healthcare group that also includes SRL, a major Japanese commercial clinical laboratory organization. The Fujirebio group has more than 1,400 employees globally according to company and reference descriptions, with manufacturing and operating capabilities in Japan, Europe, and the United States. Its current positioning centers on combining specialized biomarkers, scalable automated platforms, international regulatory and manufacturing capabilities, and partnerships across the IVD value chain.

Fujirebio was established in Tokyo in 1950 under the name Fujizoki Pharmaceutical Co., Inc. The business initially developed and manufactured pharmaceutical products. Its transition into in vitro diagnostics began with the launch of a TPHA hemagglutination kit for syphilis in 1966. The product became an early foundation for the company’s subsequent focus on laboratory diagnostics and infectious-disease testing. The company expanded its international footprint during the 1980s, establishing Fujirebio Taiwan in 1981 and Fujirebio America in 1987. In 1983, the Japanese parent adopted the Fujirebio name. During the late 1990s and 2000s, acquisitions became an important mechanism for broadening its technology base and geographic reach. In 1998, Fujirebio acquired Centocor Diagnostics of Pennsylvania, a company associated with oncology testing and assays such as CA125II, CA19-9, and CA15-3. In 2006, it acquired Sweden-based CanAg Diagnostics, adding further oncology biomarker expertise. Fujirebio continued to build its diagnostic infrastructure through acquisitions and product development. It acquired Advanced Life Science Institute and American Biological Technologies in 2008. The company also introduced the CL4800 system in Japan in 2007 to support blood screening for the Japanese Red Cross Society; the system remained in use for a number of years. In 2010, Fujirebio acquired Innogenetics N.V. of Belgium, a specialist in molecular and immunoassay diagnostics. Innogenetics subsequently became Fujirebio Europe N.V. and helped strengthen the group’s European development, manufacturing, and commercial capabilities. A major corporate reorganization occurred in 2005, when Fujirebio and the commercial laboratory company SRL were brought together under Miraca Holdings. Miraca Holdings was renamed H.U. Group Holdings in 2020. In 2017, Fujirebio Holdings, Inc. was established as a parent structure for Fujirebio Inc., Fujirebio Diagnostics, Fujirebio Europe, and other group companies. This structure supported a more coordinated international operating model while retaining specialized regional subsidiaries. The group expanded its business platform during the late 2010s and early 2020s. Fujirebio Diagnostics Japan was established in 2019 to focus on original-equipment-manufacturing business in Japan, and Fujirebio China was established in 2020. In 2022, Fujirebio acquired ADx NeuroSciences, a Belgian biotechnology company focused on neurological biomarkers, and Fluxus, Inc. These transactions supported a strategic move beyond traditional oncology and infectious-disease testing toward neurodegenerative disease diagnostics. In 2025, Fujirebio acquired Plasma Services Group, Inc. and received FDA 510(k) clearance for the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test. The regulatory milestone placed the company at the forefront of blood-based Alzheimer’s disease biomarker testing in the United States. Today, Fujirebio operates as a consolidated subsidiary of H.U. Group Holdings and supplies diagnostic reagents, instruments, software, and development and manufacturing services across international markets. Its operating model combines proprietary biomarker and assay development with the Lumipulse automated platform, regional manufacturing, partnerships, and contract services for other diagnostic companies.

1. 2025Blood-based Alzheimer’s test receives FDA clearance

   The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test received FDA 510(k) clearance.

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2. 2022ADx NeuroSciences and Fluxus acquired

   The acquisitions broadened the company’s capabilities in neurological biomarkers and related diagnostic technologies.

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3. 2017Fujirebio Holdings established

   A holding structure was created for Fujirebio’s principal Japanese, European, American, and other group companies.

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4. 2010Innogenetics acquired

   The Belgian diagnostics company strengthened Fujirebio’s molecular and specialty immunoassay activities in Europe.

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5. 2006CanAg Diagnostics acquired

   The Swedish company expanded Fujirebio’s expertise in oncology biomarker development.

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6. 1998Centocor Diagnostics acquired

   The acquisition added U.S. oncology diagnostic capabilities and tumor-marker assays.

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7. 1987U.S. presence established

   Fujirebio America was established in the United States and later became part of Fujirebio Diagnostics.

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8. 1983Company renamed Fujirebio

   The company changed its name from Fujizoki Pharmaceutical to Fujirebio Inc.

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9. 1981Fujirebio Taiwan established

   The company established a Taiwan subsidiary as part of its international expansion.

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10. 1966First IVD product launched

    The company launched a TPHA hemagglutination kit for syphilis testing, beginning its sustained focus on in vitro diagnostics.

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11. 1950Company founded as Fujizoki Pharmaceutical

    Fujizoki Pharmaceutical Co., Inc. was founded in Tokyo and initially operated as a pharmaceutical developer and manufacturer.

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An international IVD specialist combining biomarker discovery, automated immunoassay platforms, specialty diagnostics, manufacturing, and partnership-based development services. Fujirebio is especially associated with oncology testing and emerging blood-based neurological diagnostics.

• Lumipulse G seriesAutomated chemiluminescent enzyme immunoassay platform

  Lumipulse G is Fujirebio’s fully automated chemiluminescent enzyme immunoassay platform. It is designed to run a broad menu of clinical assays using standardized automation, supporting applications in oncology, infectious diseases, endocrinology, and neurological testing. The platform is central to Fujirebio’s strategy of pairing internally developed biomarkers with a proprietary analyzer and reagent ecosystem.

• Lumipulse G pTau 217/β-Amyloid 1-42 Plasma RatioNeurological disease in vitro diagnostic test2025

  This blood-based assay measures phosphorylated tau 217 and beta-amyloid 1-42 in plasma and reports a ratio intended to aid identification of amyloid pathology associated with Alzheimer’s disease. It received FDA 510(k) clearance in May 2025 and represents Fujirebio’s expansion into clinically relevant neurodegenerative disease biomarkers.

• Tumor-marker assay portfolioOncology immunoassays

  Fujirebio’s oncology portfolio includes assays for tumor-associated markers such as CA125II, CA19-9, and CA15-3. These products originated or were strengthened through the company’s acquisitions of Centocor Diagnostics and CanAg Diagnostics. They are used in laboratory workflows supporting cancer-related assessment and monitoring, subject to the indications and regulatory status applicable in each market.

• TPHA syphilis testing kitInfectious-disease diagnostic reagent1966

  The TPHA kit was Fujirebio’s first in vitro diagnostic product, launched in 1966 for syphilis testing. It marked the company’s move from pharmaceutical manufacturing into laboratory diagnostics and established an early position in infectious-disease serology.

• CL4800Blood-screening system2007

  CL4800 was a Fujirebio system introduced in Japan to support blood screening for the Japanese Red Cross Society. Its deployment demonstrated the company’s ability to provide large-scale automated laboratory infrastructure in addition to individual diagnostic reagents.

• Contract development and manufacturing servicesIVD CDMO services

  Fujirebio provides development, manufacturing, and regulatory support to third-party diagnostic companies. The service model can encompass assay and biomarker development, production, platform integration, and market-oriented support, allowing partners to use Fujirebio’s technical and manufacturing infrastructure without relying solely on their own facilities.

• 2025FDA clearance of Lumipulse Alzheimer’s biomarker testProduct launch

  Fujirebio sought regulatory validation for a blood-based test capable of aiding identification of Alzheimer’s-associated amyloid pathology.

  What changed. The FDA granted 510(k) clearance to the Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test.

  Aftermath. The clearance strengthened Fujirebio’s position in neurodiagnostics and established an important U.S. regulatory milestone for blood-based Alzheimer’s testing.

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• 2025Acquisition of Plasma Services GroupM&A

  Fujirebio continued to build capabilities related to plasma-based diagnostic development and manufacturing.

  What changed. The company acquired Plasma Services Group, Inc.

  Aftermath. The acquisition expanded Fujirebio’s plasma-related capabilities and complemented its blood-based biomarker strategy.

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• 2022Acquisition of ADx NeuroSciencesM&A

  Fujirebio identified neurological biomarkers and neurodegenerative disease testing as a strategic growth area.

  What changed. The company acquired Belgian biotechnology company ADx NeuroSciences for €40 million.

  Aftermath. The transaction added neurological biomarker research capabilities and supported development of blood-based and other neurodiagnostic tests.

  Acquisition price. €40 million (2022)

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• 2022Acquisition of FluxusM&A

  Fujirebio continued to expand its technology and development platform through targeted acquisitions.

  What changed. The company acquired Fluxus, Inc.

  Aftermath. Fluxus became part of Fujirebio’s broader diagnostics and development organization.

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• 2017Creation of Fujirebio HoldingsStrategy

  The company needed a coordinated structure for its expanding collection of regional diagnostics subsidiaries.

  What changed. Fujirebio Holdings, Inc. was established as a parent company for Fujirebio Inc., Fujirebio Diagnostics, Fujirebio Europe, and other group entities.

  Aftermath. The reorganization created a clearer international holding and operating structure for Fujirebio’s diagnostics businesses.

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• 2010Acquisition of InnogeneticsM&A

  Fujirebio aimed to broaden its European presence and add specialized molecular and immunoassay expertise.

  What changed. Fujirebio acquired Innogenetics N.V. of Belgium.

  Aftermath. The business became Fujirebio Europe N.V., supporting the group’s European research, manufacturing, and commercial operations.

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• 2006Acquisition of CanAg DiagnosticsM&A

  Fujirebio pursued specialist capabilities in oncology biomarker development.

  What changed. The company acquired Sweden-based CanAg Diagnostics AB.

  Aftermath. CanAg became part of Fujirebio’s international diagnostics structure and reinforced its oncology assay development activities.

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• 1998Acquisition of Centocor DiagnosticsM&A

  Fujirebio sought to expand its presence in the United States and strengthen its oncology diagnostics capabilities.

  What changed. The company acquired Centocor Diagnostics of Pennsylvania, bringing oncology testing assets and tumor-marker products into the Fujirebio organization.

  Aftermath. The acquired business became associated with Fujirebio Diagnostics and contributed assays including CA125II, CA19-9, and CA15-3 to the group’s oncology portfolio.

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• 2025Fujirebio receives FDA 510(k) clearance for Lumipulse blood-based Alzheimer’s biomarker test

  The U.S. Food and Drug Administration cleared Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test. The assay is intended to aid identification of amyloid pathology associated with Alzheimer’s disease and was described as the first FDA-cleared blood-based IVD test for that purpose.

  Product launchRegulationProduct generation
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• 2025Fujirebio acquires Plasma Services Group

  Fujirebio acquired Plasma Services Group, Inc., expanding its capabilities and assets in plasma-related diagnostic development and manufacturing.

  M&A
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• 2022Fujirebio acquires ADx NeuroSciences

  Fujirebio acquired Belgian biotechnology company ADx NeuroSciences for €40 million, adding neurological biomarker research capabilities and strengthening its neurodegenerative disease diagnostics portfolio.

  M&A
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• 2022Fujirebio acquires Fluxus

  Fujirebio acquired Fluxus, Inc. as part of its expansion in diagnostic technologies and related development capabilities.

  M&A
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• 2020Fujirebio establishes Fujirebio China

  The company established Fujirebio China Co., Ltd., supporting its commercial and operational presence in the Chinese market.

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1. Fujirebio
2. Fujirebio official website