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# Alzheimer’s Assay Gets Breakthrough Designation
- URL: https://www.fdaweb.com/alzheimers-assay-gets-breakthrough-designation/
- Published: 2025-01-28T12:00:00.000Z
- Updated: 2026-09-14T14:51:53.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5158562

FDA has granted Beckman Coulter Diagnostics a breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio assay, a blood test to help identify patients with amyloid pathology associated with Alzheimer’s disease. The company says the assay 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,” it says.