February 2025—Beckman Coulter Diagnostics announced the FDA has granted breakthrough device designation to the Access p‑Tau217/β-Amyloid 1-42 plasma ratio. The blood test measures the ratio of phosphorylated tau protein (pTau217) to beta‑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 noninvasive, accessible, and earlier method of detecting Alzheimer’s-related pathology, potentially before clinical symptoms manifest, the company said in a statement.
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