Fujirebio and Agappe collaborate in the field of CLIA-based immunoassay

Fujirebio Holdings, Inc. and Agappe Diagnostics Ltd have entered into an agreement of Contract Development and Manufacturing Organization (CDMO) partnership for a cartridge-based CLIA system reagents manufacturing project for the immunology equipment Mispa i60 and Mispa i121. 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.

Agappe and Fujirebio are planning 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 involve 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 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. The 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.

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