FDA Grants Breakthrough Device Designation for Beckman Coulter Alzheimer's Blood Test

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FDA Grants Breakthrough Device Designation for Beckman Coulter Alzheimer's Blood Test

Summary: The FDA has granted Breakthrough Device Designation to Beckman Coulter’s Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, a tool aimed at aiding early and accurate detection of Alzheimer’s disease. Takeaways: Innovative Detection Method: The Access p-Tau217/β-Amyloid 1-42 blood test offers a non-invasive approach to identifying amyloid pathology, a hallmark of Alzheimer’s disease, potentially transforming early diagnosis and tre…