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Beckman Coulter’s Alzheimer’s Blood Test Receives FDA Breakthrough Device Designation

NextEdge Admin

30 Jan 2025

2 min 41 sec

Beckman Coulter Diagnostics announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to its Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test. This test is designed to aid in identifying amyloid pathology associated with Alzheimer’s disease.

“We are honored to receive this designation, which marks a significant step toward earlier and more accurate detection of Alzheimer’s-related pathology,” said Kathleen Orland, Senior Vice President, Clinical Chemistry and Immunoassay at Beckman Coulter Diagnostics. “This recognition underscores the potential of our test to transform Alzheimer’s diagnosis and management, improving outcomes for patients and families.”

Paul Beresford, Neurology Franchise Head at Danaher Diagnostics, emphasized the company’s commitment to accelerating diagnostic innovations. “Beckman Coulter’s Breakthrough Device Designation for the p-Tau217/β-Amyloid 1-42 test is a milestone in our efforts to advance neurodegenerative disease diagnostics,” he said.

The test measures the ratio of phosphorylated tau protein (p-Tau217) to β‑Amyloid 1-42, two key biomarkers linked to Alzheimer’s disease. A blood-based in vitro diagnostic (IVD) test could enable earlier and non-invasive detection, potentially before symptoms appear. Early diagnosis is essential for timely intervention and patient stratification in clinical trials, driving progress in Alzheimer’s research and treatment.

Orland added that Beckman Coulter is committed to expanding its neurodegenerative disease test portfolio. With the aging population and emerging Alzheimer’s treatments, demand for high-throughput, accurate testing is expected to rise. The company’s DxI 9000 Immunoassay Analyzer, paired with its Lumi-Phos PRO substrate, supports the development of precise neurological biomarker assays.

The FDA’s Breakthrough Device Designation program fast-tracks the development of innovative medical devices, offering regulatory support to expedite their path to market and benefit public health.