Beckman Coulter receives FDA Breakthrough Device Designation for Alzheimer’s disease blood test
Beckman Coulter Diagnostics announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Beckman Coulter's Access p‑Tau217/β-Amyloid 1-42 plasma ratio.
This blood test is designed to aid healthcare providers 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 key biomarkers implicated in the neurodegenerative processes of Alzheimer's disease. A blood-based IVD test that can quantify these biomarkers in plasma could provide a non-invasive, accessible, and earlier method of detecting Alzheimer's-related pathology. This capability is important for improving early diagnosis, enabling timely intervention, and stratifying patients for therapeutic trials, ultimately accelerating progress in Alzheimer's research and treatment.
