Fujirebio Diagnostics, Inc. - US In Vitro Diagnostics Manufacturing Leader

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📢 Important Milestones (2025-2026):
Fujirebio Diagnostics, Inc. continues to expand its manufacturing capabilities at its 190,000-square-foot Malvern, PA facility, implementing advanced Manufacturing Execution Systems (MES) to increase automation and reduce human error. The company manufactures over one million test kits annually, supporting approximately 150 million patient tests worldwide. In 2025, the company maintained ISO13485/MDSAP certification across all manufacturing sites and achieved 90% employee engagement scores.

Company Overview (Updated April 2026)

Fujirebio Diagnostics, Inc. is the US subsidiary of Fujirebio Inc., a global leader in in vitro diagnostics headquartered in Tokyo, Japan. Founded in 1988 (originally as Centocor Diagnostics before acquisition by Fujirebio), the company is headquartered in Malvern, Pennsylvania. The company specializes in the manufacturing and commercialization of high-quality IVD products, with particular expertise in oncology biomarkers and neurodegenerative disease diagnostics.

Mission: To deliver quality and value with products that have made the company the standard of excellence in the industry, developing new, innovative diagnostic products that aid healthcare professionals in the treatment of human disease.

Corporate History and Strategic Acquisitions

Founding and Early Development (1988-1998)

- 1988: Founded as Centocor Diagnostics in Malvern, Pennsylvania, pioneering the development of monoclonal antibody-based diagnostic products

- 1998: Acquired by Fujirebio Inc. for $37.5 million, becoming Fujirebio Diagnostics, Inc. and establishing Fujirebio's presence in the US market

Expansion Through Acquisitions (2006-2010)

- 2006: Acquired CanAg Diagnostics AB (Sweden), a leader in oncology biomarker development, expanding the company's cancer diagnostic portfolio

- 2008: Acquired American Biological Technologies (Seguin, Texas), adding manufacturing capacity for IVD assay controls and calibrators

- 2010: Contributed to Fujirebio's acquisition of Innogenetics N.V. (Belgium), gaining expertise in neurodegenerative disease diagnostics including Alzheimer's biomarkers

Modern Manufacturing Excellence (2020-2026)

- 2020-2026: Implemented Manufacturing Execution Systems (MES) at the Malvern facility to increase automation, improve quality control, and expand production capacity

- 2025: Achieved 90% employee engagement scores and maintained ISO13485/MDSAP certification across all manufacturing sites

Core Business and Product Portfolio

Manufacturing Capabilities

Fujirebio Diagnostics specializes in:

- Manual Assay Products: EIA (Enzyme Immunoassay) kits, including the preserved CanAg brand EIA kits for oncology testing

- Reagents and Controls: High-quality reagents, calibrators, and controls for IVD testing distributed throughout the US and worldwide

- OEM Solutions: Custom-developed products and contract manufacturing for leading diagnostic companies through a worldwide network of distribution partners

- Neurodegenerative Disease Assays: Manufacturing support for LumiPulse platform neurological biomarkers including pTau 217, β-Amyloid, and NfL assays

Key Product Lines

- Oncology Biomarkers: Industry-leading tumor marker assays including CA125 II, CA19-9, CA15-3 (pioneered by Centocor Diagnostics over 25 years ago)

- Infectious Disease Testing: Assays for infectious disease diagnosis

- Cardiac Markers: Diagnostic tests for cardiac conditions

- Multi-constituent Controls: Advanced quality control products

- Enzyme Conjugate Stabilizers: Specialized reagents for assay stability

Global Manufacturing Footprint

US Manufacturing Facilities:

- Malvern, Pennsylvania (Headquarters): 190,000-square-foot state-of-the-art facility; largest of three global manufacturing sites with approximately 350 employees

- Seguin, Texas: Acquired 2008; manufacturing facility for IVD controls and calibrators

International Manufacturing:

- Gothenburg, Sweden: Former CanAg Diagnostics facility; oncology biomarker manufacturing

- Tokyo, Japan: Parent company Fujirebio Inc. manufacturing

Total Manufacturing Space: Approximately 65,000 square feet across US and Sweden (as of 2023)

Quality Standards and Certifications

- ISO 13485:2016: Medical device quality management system certification

- MDSAP (Medical Device Single Audit Program): Certified across all three manufacturing sites (Malvern, PA; Seguin, TX; Gothenburg, Sweden)

- CE Marking: Products meet European IVD Directive 98/79/EC requirements

- FDA Registration: Registered with US FDA for IVD manufacturing (Registration Number: 2521625, FEI: 2521625)

- Quality Excellence: Manufacturing Execution System (MES) implementation to eliminate human error and ensure consistent product quality

Operational Highlights (2026)

Production Capacity:

- Manufactures over one million test kits annually

- Supports approximately 150 million patient tests per year

Manufacturing Innovation:

- Electronic batch records replacing paper systems

- Automated chemical addition processes reducing need for dual technician verification

- Capacity optimization allowing single operators to run independent processes

Workforce Engagement:

- Approximately 220 employees in the US (350 at Malvern facility)

- 90% employee engagement rate (2025 survey)

- Over 25% highly engaged workforce classification

Leadership and Governance

Executive Leadership

Key Principal: Takeo Hayashi (per Dun & Bradstreet records)

Official Correspondent: Gregory Dickson (Phone: 610-240-3888; Email: dicksong@fdi.com)

Parent Company Leadership:

- Goki Ishikawa: President & CEO, Fujirebio Holdings, Inc. and Fujirebio Inc.

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

Regulatory Status and Compliance

- FDA Establishment Registration: Active (2026 status)

- Recall History: Class 2 Device Recall initiated December 11, 2025 for Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio (Z-1301-2026); corrective actions implemented

- US Manufacturing: All products manufactured under strict FDA QSR compliance