Blood Test Helps Identify Patients with Alzheimer's Associated Amyloid Pathology

Image: The U.S. FDA has granted Breakthrough Device Designation to the Access p‑Tau217/β-Amyloid 1-42 plasma ratio Test (Photo courtesy of Beckman Coulter)

Neurological diseases, such as Alzheimer's disease, are becoming an increasing cause of death and disability among older adults worldwide, posing significant challenges to healthcare systems. These conditions are complex and diverse, presenting a range of symptoms that complicate diagnosis. To address these challenges, a new blood test has been developed to help healthcare providers detect amyloid pathology associated with Alzheimer’s disease.

The Access p‑Tau217/β-Amyloid 1-42 plasma ratio, developed by Beckman Coulter Diagnostics (Brea, CA, USA), is a blood test that measures the ratio of phosphorylated tau protein (p-Tau217) and β‑Amyloid 1-42, both of which are key biomarkers involved in the neurodegenerative processes of Alzheimer's disease. This blood-based in vitro diagnostic (IVD) test is capable of quantifying these biomarkers in plasma, providing a non-invasive, accessible, and earlier method to detect Alzheimer’s-related pathology. Early detection is crucial for improving diagnosis, enabling timely interventions, and identifying patients for therapeutic trials, all of which can help accelerate progress in Alzheimer’s research and treatment. The Access p‑Tau217/β-Amyloid 1-42 plasma ratio has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

"We are honored 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."