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 test.
This blood test is designed to help healthcare professionals identify amyloid pathology associated with Alzheimer’s disease.
The test measures the ratio of phosphorylated tau protein (p-Tau217) to β Amyloid 1-42, two biomarkers linked to Alzheimer’s disease.
A blood-based diagnostic test capable of detecting these biomarkers could offer a non-invasive and accessible method for early detection of the disease, potentially before symptoms appear.
Early diagnosis is crucial for timely intervention and patient management, as well as for identifying suitable candidates for clinical trials.
This designation highlights the test’s potential to improve Alzheimer’s diagnosis and management.
Beckman Coulter Diagnostics is also developing a range of advanced tests for neurodegenerative diseases to meet the increasing demand for Alzheimer’s diagnostics.
The company’s DxI 9000 Immunoassay Analyser, combined with its Lumi-Phos PRO technology, supports the development of precise, high-throughput assays that can detect neurological biomarkers efficiently.
The FDA Breakthrough Device Designation programme is designed to accelerate the development and review of medical devices that offer significant improvements in diagnosing or treating serious conditions.
It provides regulatory support to help bring innovative solutions to market more efficiently, ultimately benefiting both patients and healthcare providers.
