
Beckman Coulter Diagnostics has been granted a U.S. Food and Drug Administration (FDA) breakthrough device designation for its Access p‑Tau217/β-Amyloid 1-42 assay, designed to identify amyloid pathology indicative of 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 important biomarkers that are hallmarks of the neurodegenerative processes of Alzheimer's, Beckman Coulter said in a statement.
The firm noted that a blood-based IVD test for assessing these biomarkers in plasma, such as its Access p‑Tau217/β-Amyloid 1-42 assay, could provide a noninvasive, accessible method of detecting Alzheimer’s-related pathology, potentially even before clinical symptoms have developed. The assay could enable earlier diagnosis, resulting in earlier intervention and better patient outcomes, as well as assisting in stratifying patients for therapeutic trials, therefore accelerating research in Alzheimer's treatment.
"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," Kathleen Orland, senior vice president, general manager, clinical chemistry and immunoassay for Beckman Coulter, said. "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."