USA —In a strategic partnership poised to transform Alzheimer’s disease diagnostics, Beckman Coulter, a clinical diagnostics frontrunner under Danaher, has joined forces with Japanese biotechnology trailblazer Fujirebio.
The collaboration seeks to pioneer blood-based tests for Alzheimer’s disease, representing a pivotal step towards accessible diagnostic solutions in anticipation of burgeoning demand, fueled by advancements in the realm of potential neurodegenerative treatments.
Beckman Coulter’s ambitions extend to amplifying its role in delivering accessible and effective diagnostic assays for Alzheimer’s.
The objective is to proactively address the surging need, driven by breakthroughs that hold promise in mitigating the impact of this relentless condition on the human brain.
This partnership announcement underscores Beckman Coulter’s strategic alignment with Fujirebio, with a specific focus on the co-development and market deployment of blood-based tests tailored for Alzheimer’s disease.
The collaborative endeavor aims to harness the neurological biomarker and assay expertise of Fujirebio and fuse it with the expansive global installation base of lab hardware possessed by Beckman Coulter.
The timing of this alliance is particularly noteworthy, coinciding with the significant FDA approval of Eisai and Biogen’s Leqembi.
This landmark decision granted full authorization for the lecanemab antibody, which exhibited a remarkable ability to curtail the progression of Alzheimer’s and potentially slow down cognitive decline.
Meanwhile, Eli Lilly has unveiled compelling clinical data surrounding its contender, donanemab, envisaging a potential FDA clearance by year’s end.
Both these pharmaceutical advancements, along with over 100 other disease-modifying therapies in the industry pipeline, as highlighted by Beckman Coulter and Fujirebio, could greatly benefit from a universally accessible Alzheimer’s diagnostic tool, especially during pivotal clinical investigations.
Elevating the promise of a blood-based diagnostic approach, the collaboration aims to offer an economical and convenient alternative to current standards, such as PET imaging scans of the brain and lumbar punctures to obtain cerebrospinal fluid.
Notably, this initiative is not exclusive, as other industry players like C2N Diagnostics, Roche, and the recent entrant Quanterix, are also diligently pursuing blood-based diagnostic avenues.
The genesis of this partnership will center around Beckman Coulter’s DxI 9000 Access immunoassay analyzer, leveraging its cutting-edge capabilities.
Fujirebio is poised to validate the clinical performance of blood-based biomarkers and subsequently secure regulatory approvals from authorities in the United States, Europe, and Japan.
Tokyo-based Fujirebio has previously secured FDA authorization for an Alzheimer’s in vitro diagnostic, a remarkable feat that exemplifies its expertise.
The company has also constructed an array of research-use-only tests centered on blood-based biomarkers, including beta-amyloid, phosphorylated tau proteins, neurofilament light chain, and apolipoprotein E.
Moreover, the partnership’s ambitions extend beyond Alzheimer’s diagnostics, resonating with Fujirebio’s dedication to the realm of neurodegenerative disease diagnostics, a facet underscored by its acquisition of Belgian assay developer ADx NeuroSciences last year, a transaction amounting to 40 million euros (US$ 43.7 million).
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