The FDA has granted medical manufacturer Beckman Coulter a Breakthrough Device Designation for its new plasma ratio, a blood test that could help healthcare providers identify patients with amyloid pathology associated with Alzheimer's disease.
The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test measures the ratio of phosphorylated tau protein to β‑Amyloid 1-42, biomarkers associated with the neurodegenerative effects of Alzheimer's disease. The blood-based diagnostic test could quantify these biomarkers in plasma and provide an earlier method of detecting Alzheimer's-related pathology. Earlier diagnosis would result in more timely intervention.
Most Read Medical News:
- Hand Exoskeleton Provides Complete Sense of Touch for Medical Training
- Tongue Implant Could Treat Sleep Apnea Without a CPAP
- Motif Neurotech Wins Award to Develop Therapeutic Brain-Computer Interface
- Aptyx Acquires Medical Murray’s North Carolina Facility
"Focusing on shortening the time it takes to bring innovative assays to clinicians and patients is a core tenet of Danaher Diagnostics," said Paul Beresford, Neurology Franchise Head, Danaher Diagnostics. "This exciting announcement that Beckman Coulter's Access p Tau217/β-Amyloid 1-42 Plasma Ratio blood test received Breakthrough Device Designation from the FDA is another proof point demonstrating our progress in developing a portfolio of clinical diagnostics tests for neurodegenerative diseases, starting with Alzheimer's disease. We believe that by taking such a disease-focused approach, Danaher Diagnostics and its operating companies are able to develop more innovative and patient-friendly clinical solutions.
The FDA Breakthrough Device Designation program expedites the development and review of medical devices offering significant advancements in treating or diagnosing life-threatening or debilitating diseases. It provides prioritized review, enhanced communication, and regulatory support to help manufacturers bring innovative devices to market more efficiently, ultimately benefiting patients and public health.
