Beckman Coulter's Blood Test for Alzheimer's Gets FDA Breakthrough Status

Beckman Coulter Diagnostics, a worldwide frontrunner in clinical diagnostics, declared that the US Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to Beckman Coulter's Access p-Tau217/ß-Amyloid 1-42 plasma ratio. This blood test aims to assist healthcare professionals in identifying patients with amyloid pathology linked to Alzheimer's disease.

“We are honoured to receive Breakthrough Device Designation from the US FDA for our p-Tau217/ß-Amyloid 1-42 assay, a significant step forward in addressing the urgent need for earlier and more accurate detection of Amyloid pathology, a hallmark of Alzheimer’s disease,” said Kathleen Orland, senior vice president, general manager, clinical chemistry and immunoassay for Beckman Coulter Diagnostics. “This designation reflects the potential of our test to transform how Alzheimer’s disease is diagnosed and managed, ultimately leading to improved outcomes for patients and families affected by this devastating disease."

“Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics,” said Paul Beresford, Neurology Franchise Head, Danaher Diagnostics. “This exciting announcement that Beckman Coulter’s Access p Tau217/ß-Amyloid 1-42 Plasma Ratio blood test received Breakthrough Device Designation from the FDA is another proof point demonstrating our progress in developing a portfolio of clinical diagnostics tests for neurodegenerative diseases, starting with Alzheimer’s disease. We believe that by taking such a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions."