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.
