Fujirebio and Agappe Collaborate on CLIA-Based Immunoassay

Fujirebio Holdings (Tokyo, Japan) and Agappe Diagnostics (Kochi, India) have entered into a Contract Development and Manufacturing Organization (CDMO) partnership for manufacturing cartridge-based CLIA system reagents for the Mispa i60 and Mispa i121 immunology analyzers. These analyzers and reagents will be sold under Agappe’s brand, making it the first Indian local company with a complete chemiluminescence solution made from reagents produced domestically.

The companies have outlined plans to launch these products in June 2024. Significant milestones have already been achieved, including the finalization of a supply and license agreement in March 2023. Agappe is currently in the advanced stages of technical transfer from Fujirebio, which will enable the Indian company to manufacture chemiluminescence reagents using Fujirebio’s technology and materials. The collaboration is set to make a substantial impact, with phased launches planned for a complete range of over 30 parameters, spanning various medical segments such as oncology, thyroid, cardiac, fertility, and infectious diseases. Additionally, Fujirebio’s groundbreaking biomarkers for Alzheimer’s and other neurodegenerative diseases are also included in this project.

Image: The Mispa i4 fully automated cartridge based specific protein analyzer and clinical chemistry analyzer (Photo courtesy of Agappe)

Under this agreement, Fujirebio will be responsible for supplying the Mispa i60 and i121 analyzers and the raw materials for the reagents. Agappe, on the other hand, will focus on developing and manufacturing reagents specifically tailored for these instruments, ensuring compliance with all regulatory requirements. This partnership is based on a shared vision of leveraging each company’s unique strengths to not only foster growth in India's immunoassay market but also to significantly contribute to the advancement and enhancement of immunoassay solutions within the Indian healthcare sector.

“This partnership with Agappe, the renowned market leader with years of success in clinical chemistry, hematology, immunochemistry, and point of care in India, will accelerate our CDMO strategy in one of the most important and fastest growing countries in the world,” said Goki Ishikawa, President and CEO, Fujirebio Holdings, Inc. “We share a vision that, combining mutually complementary strengths of both companies, Agappe together with Fujirebio can deliver high-quality chemiluminescence solutions with cost competitiveness and contribute to the healthcare advancement in India.”

“Leveraging the combined strengths of Agappe and Fujirebio, we are committed to introducing high quality, affordable, and unique chemiluminescence solutions for the country,” added Thomas John, Managing Director, Agappe Diagnostics, Ltd. “This partnership symbolizes our dedication to innovation and our pledge to make advanced diagnostic products more accessible to every Indian. We are poised to set new benchmarks in the industry, emphasizing our joint endeavor to enhance healthcare standards across our nation."

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Fujirebio Holdings 
Agappe Diagnostics