TOKYO & COCHIN, India--(BUSINESS WIRE)--#IVD--Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd today announced that they have entered into an agreement of Contract Development and Manufacturing Organization (CDMO) partnership for Cartridge based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121. Notably, the analyzers and reagents will be sold under Agappe’s brand, making Agappe the first Indian local company with a complete Chemiluminescence Solution comprising locally manufactured reagents.

In a significant move, Agappe and Fujirebio have revealed plans to launch these products in June 2024. The project has already achieved significant progress, including the signing of a Supply and License Agreement in March 2023. Agappe is at the advanced stages of technical transfer from Fujirebio, enabling them to manufacture Chemiluminescence Reagents using Fujirebio’s technology and materials.

This initiative is set to be impactful, involving the phased launches of the entire range of more than 30 parameters across diverse segments, including Oncology, Thyroid, Cardiac, Fertility, and Infectious Diseases. Fujirebio’s innovative biomarkers for Alzheimer’s disease and other neurodegenerative disease are also in the scope. Fujirebio will supply the equipment Mispa i60 & i121 and reagent raw materials, while Agappe will develop and manufacture dedicated reagents for the equipment, complying with all regulatory formalities. This collaboration is driven by a mutual belief that leveraging their distinct strengths will not only spur the expansion of India's immunoassay market but also significantly impact the evolution and enhancement of immunoassay solutions in India.

“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. 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, emphasising our joint endeavour to enhance healthcare standards across our nation,” stated Thomas John, Managing Director, Agappe Diagnostics, Ltd.

About Fujirebio

Fujirebio, a member of H.U. Group Holdings Inc., is global R&D-driven company constantly developing new in vitro diagnostics testing technologies and unique biomarkers with high clinical value. Our group mission is to create new value in healthcare and thereby contribute to human health and the future of medical care.

Our global teams located in Japan, Asia, Europe, and the US focus on delivering products with the highest quality standards to our customers and partners. We value partnerships with other leading companies in the industry, sharing knowledge, capabilities, and critical materials to supply, develop, or manufacture diagnostic solutions on a wide variety of platforms.

For more information about Fujirebio, please visit www.fujirebio.com.

About Agappe

Agappe, your best partner in diagnostics, with a 28-year legacy, leads the way in Clinical Chemistry, Hematology, Immunochemistry, and Point of Care Tests. At the heart of their innovation is a relentless dedication to Research and Development. They excel in providing high-quality, affordable diagnostic solutions, forging strong and lasting connections with clients through unique product basket.

Looking ahead, Agappe envisions being a global frontrunner in In-Vitro Diagnostics, more than a business entity, aiming to significantly enhance human welfare through innovative, quality and affordable diagnostics solutions.

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