Fujirebio Inc. - Global In Vitro Diagnostics Leader

Company Overview (Updated April 2026)

Fujirebio Inc. is a global leader in in vitro diagnostics (IVD) headquartered in Tokyo, Japan (Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku). Founded in 1950, the company is a wholly-owned subsidiary of H.U. Group Holdings, Inc. (listed on Tokyo Stock Exchange: TYO: 4544). The company specializes in developing, manufacturing, and commercializing IVD products, with particular expertise in immunodiagnostics for infectious diseases, oncology, and neurological disorders.

Mission: To create new value in healthcare and contribute to human health and the future of medical care through the development of high-quality diagnostic solutions and novel biomarkers with high clinical value.

Corporate History and Strategic Development (1950-Present)

Founding and Expansion (1950-2010)

- 1950: Founded in Tokyo, Japan, beginning operations as a specialized IVD company

- 1998: Acquired Centocor Diagnostics, expanding immunoassay capabilities

- 2006: Acquired CanAg Diagnostics, strengthening oncology portfolio

- 2010: Acquired Innogenetics, enhancing presence in Europe and infectious disease testing

Modern Era and Global Partnerships (2024-2026)

- December 2024: Signed memorandum of understanding with Eisai Co., Ltd. for joint research and social implementation of novel blood-based biomarkers in neurodegenerative diseases

- March 2024: Expanded partnership with Beckman Coulter Diagnostics for development, manufacturing, and clinical adoption of neurodegenerative disease assays

- February 2026: Entered sales collaboration with Sysmex Corporation for joint distribution of Lumipulse G immunoassay systems and reagents

Core Product Portfolio: LUMIPULSE® Systems

LUMIPULSE® G Series Analyzers

The LUMIPULSE® G series comprises fully automated chemiluminescent enzyme immunoassay (CLEIA) systems:

LUMIPULSE G1200:

- Mid-sized fully automated immunoassay analyzer

- Throughput: 120 tests per hour

- Technology: Chemiluminescent enzyme immunoassay (CLEIA)

- Certification: CE marked under EU IVDR (Class A) since May 2022

- Applications: Oncology, infectious diseases, thyroid, fertility, diabetes, bone metabolism, and neurological markers

- Measurement time: Approximately 30 minutes per analyte

LUMIPULSE G600II:

- Compact version for smaller laboratories

Menu Options: The LUMIPULSE platform offers extensive test menus including tumor markers, autoimmune disease markers, infectious disease markers, cardiovascular and metabolic markers, and neurological biomarkers

Neurological Disease Biomarkers (2025-2026 Launches)

Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio (FDA Cleared May 2025):

- First FDA-cleared blood-based IVD test for assessment of amyloid pathology in patients being evaluated for Alzheimer's disease

- Provides less invasive alternative to CSF testing and PET scans

- Manufacturing and marketing approval application filed with Japan Ministry of Health, Labour and Welfare in November 2025

Lumipulse G pTau 217 CSF Assay (January 2026):

- Research Use Only (RUO) assay for quantitative measurement of Tau phosphorylated at threonine 217 in cerebrospinal fluid

- Results available in 35 minutes

Lumipulse G NfL Blood Assay (CE Marked March 2026):

- Quantitative measurement of neurofilament light chain (NfL) in plasma and serum

- First CE-marked blood test in Fujirebio's neurological portfolio supporting clinicians across wide range of neurological disorders

- Biomarker of neuroaxonal injury for disease monitoring, prognosis, and treatment evaluation

Other Neurological Markers:

- Lumipulse G ApoE4 and Pan-ApoE (Research Use Only) for Alzheimer's risk assessment

- Comprehensive panel for β-amyloid peptides, tau proteins, and other neurodegenerative biomarkers

Recent Achievements and Recognition (2026)

Regulatory Milestones

- First Global FDA Clearance (May 2025): Blood-based Alzheimer's disease assessment test

- EU IVDR CE Mark (March 2026): NfL blood assay for neuroaxonal injury assessment

CEO Recognition

Goki Ishikawa named to TIME100 Health 2026 (February 2026):

- Recognized in the "Pioneers" category of TIME's 2026 TIME100 Health List of the World's Most Influential Leaders in Health

- Recognized for advancing blood-based testing that expands potential for earlier diagnosis and treatment of Alzheimer's disease

Strategic Partnerships

- Sysmex Corporation (February 2026): Sales collaboration agreement to leverage Sysmex's global network for distribution of Lumipulse G systems and reagents

- Eisai Co., Ltd. (December 2024): MOU for joint research on blood-based biomarkers for neurodegenerative diseases

- Beckman Coulter Diagnostics (March 2024): Expanded partnership for neurodegenerative disease assay development

Global Presence

- Global Offices: 14 office locations across Japan, USA (Malvern, PA; Sunnyvale, CA; Philadelphia), Belgium (Ghent), China (Beijing, Shanghai), France (Paris), Germany (Hannover), Italy (Rome), and Taiwan

- Manufacturing and R&D: Operations in Japan, Belgium (Ghent), and USA (Malvern, PA)

- Distribution: Products available in 100+ countries through global distribution network

Leadership and Governance (2026)

Executive Leadership

Managing Executive Officer, H.U. Group Holdings; President & CEO, Fujirebio Holdings, Inc.: Goki Ishikawa

- Born November 18, 1976; holds 20,100 shares (as of June 2025)

- Education: B.A. Economics, University of Tokyo (1999); MBA, Harvard Business School (2006)

- Career: Boston Consulting Group (2006-2008), Elsevier (2008-2012), joined Fujirebio (2012)

- Appointed President & CEO of Fujirebio Inc. (June 2018) and Fujirebio Holdings, Inc. (June 2020)

- Assumed role as Managing Executive Officer of H.U. Group Holdings, Inc. on April 1, 2026

- Director of SRL, Inc. (since June 2023)

- Director of Fujirebio Europe N.V. and Fujirebio Diagnostics Inc. (USA)

CEO, Fujirebio Europe N.V.: Christiaan De Wilde

Company Information

Corporate Details

Legal Name: Fujirebio Inc. / Fujirebio Holdings, Inc.

Founded: 1950

Headquarters: Akasaka Intercity AIR, 1-8-1 Akasaka, Minato-ku, Tokyo 107-0052, Japan

Parent Company: H.U. Group Holdings, Inc. (Tokyo Stock Exchange: TYO: 4544)

Status: Wholly-owned subsidiary of public company

Industry: Medical Devices - In Vitro Diagnostics / Immunodiagnostics / Clinical Laboratory Testing

Employees: 1,200+ worldwide (220 in USA)

Key Subsidiaries: Fujirebio Europe N.V. (Belgium), Fujirebio Diagnostics, Inc. (USA), Fujirebio Holdings, Inc.

Contact Information

Global Website: www.fujirebio.com

Media Contact (H.U. Group): Public Relations Section, Phone: +81-3-6279-0884, Email: pr@hugp.com

Investor Relations (H.U. Group): Phone: +81-3-6279-0926, Email: ir@hugp.com

Europe: Fujirebio Europe N.V., Technologiepark 6, 9052 Gent (Zwijnaarde), Belgium

USA: Fujirebio Diagnostics, Inc., 201 Great Valley Parkway, Malvern, PA 19355

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