Beckman Coulter receives FDA breakthrough device designation for a blood test for Alzheimer's disease
Beckman Coulter Diagnostics, a global leader in clinical 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.