The Biogen, Beckman Coulter and Fujirebio partnership aims to identify new blood biomarkers that could provide more insight into the underlying pathology of Alzheimer’s and help develop new therapies. Image Credit: SewCreamStudio / Shutterstock.

Biogen, Beckman Coulter and Fujirebio have partnered to identify and develop new blood-based biomarkers for Tau pathology, a hallmark of Alzheimer’s disease.

As part of the agreement, Biogen will provide Alzheimer’s clinical study data and biomarker research expertise to prioritise tau pathology markers. Fujirebio and Beckman Coulter will be responsible for diagnostic development, manufacturing, and commercialisation.

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“Stratifying and monitoring patients for tau pathology is a growing need for the next generation of Alzheimer’s therapies, such as our pipeline of investigational tau-targeting therapies, including tau-directed ASO (antisense oligonucleotide)” said Jane Grogan, head of research at Biogen.

“Through this collaboration, we plan to leverage our deep scientific expertise in the development and use of biomarkers, combined with our partners’ capabilities in diagnostics, to potentially accelerate the development timeline for blood-based diagnostics that can measure a patient’s levels of tau pathology.”

Multiple companies are developing diagnostic blood tests for detecting Alzheimer’s. C2N Diagnostics has developed a PrecivityAD2 blood test, which can be used to screen for Alzheimer’s disease in primary care settings. The test uses high-resolution mass spectrometry to precisely measure proteins, which are then analysed using a validated algorithm to predict the likelihood of the presence of brain amyloid pathology.

In April 2024, Roche secured a breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys pTau217 plasma biomarker assay.

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Biogen is also developing multiple therapies for treating Alzheimer’s disease. The company’s main focus is Leqembi (lecanemab), which the company is codeveloping with Eisai. Biogen has also had some setbacks in this area, with its amyloid targeting therapy, Aduhelm (aducanumab), becoming a cautionary tale in the space. Despite gaining FDA approval, it had limited reimbursement and access, and in January 2024 Biogen halted its development.

Beckman Coulter and Fujirebio have a long-standing partnership to develop blood tests for neurogenerative disorders. In July 2023, the companies announced a partnership agreement to develop blood-based Alzheimer’s disease diagnostics.

This month, Fujirebio’s subsidiary HU Group launched the Lumipulse G GFAP assay in the US. The assay is intended for research use for quantitative measurement of glial fibrillary acidic protein.