Beckman Coulter, Fujirebio partner on gold rush for Alzheimer's blood tests

Beckman Coulter aims to expand its reach in accessible diagnostic tests for Alzheimer’s disease, to get ahead of potentially high demand as advancements are made in hopefully treating the neurodegenerative condition.

The company announced it has inked a partnership with Fujirebio focused on developing and marketing blood tests for Alzheimer’s—with the goal of combining the Japanese diagnostic maker’s neurological biomarker and assay experience with Beckman Coulter’s globally installed base of lab hardware.

The team-up comes in the wake of the FDA’s milestone drug approval for Eisai and Biogen’s Leqembi earlier this month, when the agency granted a full green light to the antibody lecanemab after it demonstrated reductions in Alzheimer’s progression and showed it could help slow down the rate of cognitive decline.

Meanwhile, Eli Lilly this week posted clinical data from its potential competitor, donanemab, which the Big Pharma hopes will clear the FDA by the end of this year. 

Both of these drugs—as well as the more than 100 disease-modifying therapies currently moving through the industry’s pipeline, according to Beckman Coulter and Fujirebio—would benefit from a widely accessible Alzheimer’s diagnostic, including during their clinical studies.

With a test based on a blood draw, the companies aim to provide a cheaper, easier test compared to the current standards of PET imaging scans of the brain and lumbar punctures for collecting cerebrospinal fluid.

Other companies, such as C2N Diagnostics and Roche—as well as a recent launch from Quanterix—are also chasing blood-based approaches.

The partnership’s development will begin focused on Beckman Coulter’s DxI 9000 Access immunoassay analyzer. Fujirebio said it plans to validate the clinical performance of blood-based biomarkers and bring them to regulators in the U.S., Europe and Japan.

The Tokyo-based company was also the first to obtain an FDA authorization for an Alzheimer’s in vitro diagnostic, with last year’s green light for checking beta amyloid levels in cerebrospinal fluid. 

Fujirebio has also developed a set of research-use-only tests aimed at blood-based biomarkers—including beta amyloid, phosphorylated tau proteins, neurofilament light chain and apolipoprotein E. 

In addition, the company said it would pursue neurodegenerative disease diagnostics that formed the base of its 40 million euro acquisition last year of the Belgian assay developer ADx NeuroSciences.