Beckman Coulter Diagnostics has 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.
The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test 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. This capability is important for improving early diagnosis, enabling timely intervention, and stratifying patients for therapeutic trials, ultimately accelerating progress in Alzheimer's research and treatment.
"We are honoured to receive Breakthrough Device Designation from the U.S. FDA for our p‑Tau217/β-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."
Orland continues: "Beyond the Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, Beckman Coulter is committed to developing a full suite of next-generation neurodegenerative disease tests. The aging global population combined with emerging drug treatments is expected to create widespread demand for Alzheimer's disease testing, which will require accurate, high-throughput assays."
The FDA Breakthrough Device Designation program expedites the development and review of medical devices offering significant advancements in treating or diagnosing life-threatening or debilitating diseases. It provides prioritised review, enhanced communication, and regulatory support to help manufacturers bring innovative devices to market more efficiently, ultimately benefiting patients and public health.