Beckman Coulter’s Alzheimer’s Blood Test Wins FDA Breakthrough Nod

Beckman Coulter Diagnostics has gained U.S. Food and Drug Administration (FDA) Breakthrough Device Designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease.

The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test measures the ratio of phosphorylated tau protein (p-Tau217) to β‑Amyloid 1-42—two biomarkers implicated in Alzheimer’s neurodegenerative processes. A blood-based in-vitro diagnostic test that could quantify these biomarkers in plasma could offer a non-invasive, accessible, and earlier method of spotting Alzheimer’s related pathology.

This capability is important to improve early diagnosis, enable timely intervention, and stratify patients for therapeutic trials, accelerating progress in Alzheimer’s research and treatment.

“Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics,” said Paul Beresford, Neurology Franchise Head, Danaher Diagnostics. “This exciting announcement that Beckman Coulter’s Access p Tau217/β-Amyloid 1-42 Plasma Ratio blood test received Breakthrough Device Designation from the FDA is another proof point demonstrating our progress in developing a portfolio of clinical diagnostics tests for neurodegenerative diseases, starting with Alzheimer’s disease. We believe that by taking such a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions.”

Orland continued, “Beyond the Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests. The aging global population combined with emerging drug treatments is expected to create widespread demand for Alzheimer’s disease testing, which will require accurate, high-throughput assays. The proprietary technologies on the Beckman Coulter DxI 9000 Immunoassay Analyzer coupled with its novel Lumi-Phos PRO substrate has enabled development of precise, clinically relevant assays and shown capability to detect targeted neurological biomarkers on an automated, high-throughput platform.”

In October 2024, the company began partnering with SphingoTec to bring an assay for SphingoTec’s innovative kidney function biomarker, Proenkephalin 119-159 (penKid), to Beckman Coulter’s extensive test menu for use on the Access Family of Immunoassay Analyzers.