Beckman Coulter Diagnostics has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for its Access p‑Tau217/β-Amyloid 1-42 plasma ratio blood test. Designed to aid in identifying amyloid pathology linked to Alzheimer’s disease, this test could improve early diagnosis and patient care.
The test measures phosphorylated tau protein (p-Tau217) and β‑Amyloid 1-42, two key biomarkers in Alzheimer’s progression. A blood-based diagnostic tool that detects these biomarkers non-invasively could help healthcare providers diagnose the disease earlier, enabling timely intervention and improving patient outcomes.
“This designation reflects the potential of our test to transform how Alzheimer’s is diagnosed and managed,” said Kathleen Orland, Senior Vice President at Beckman Coulter Diagnostics. “With the global population aging and new treatments emerging, the demand for accurate, high-throughput Alzheimer’s testing is set to grow.”
The FDA’s Breakthrough Device program accelerates the review of innovations that significantly improve the diagnosis or treatment of serious conditions, helping bring life-changing medical advancements to market more efficiently.
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