- Adult Immunization
- Hepatology
- Pediatric Immunization
- Screening
- Psychiatry
- Allergy
- Women's Health
- Cardiology
- Pediatrics
- Dermatology
- Endocrinology
- Pain Management
- Gastroenterology
- Geriatrics
- Infectious Disease
- Obesity Medicine
- Rheumatology
- Nephrology
- Neurology
- Pulmonology
FDA Grants Breakthrough Device Designation for Alzheimer Disease Blood Test
The Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test is designed to help identify patients with amyloid pathology associated with AD.
The US FDA has granted Breakthrough Device Designation to Beckman Coulter’s Access p-Tau217/β-Amyloid 1-42 plasma ratio blood test, the company announced January 28, 2025.This test is designed to help identify patients with amyloid pathology associated with Alzheimer disease (AD).
The Access pTau217/β-Amyloid 1-42 assay measures the ratio of phosphorylated tau protein (p-Tau217) to β-Amyloid 1-42, biomarkers involved in the neurodegenerative processes of AD. A blood-based in vitro diagnostic (IVD) test capable of quantifying these biomarkers in plasma offers a noninvasive and accessible method for earlier detection. Earlier diagnosis may facilitate timely intervention, assist in patient stratification for clinical trials, and contribute to advancements in AD research and treatment.
“We are honored to receive Breakthrough Device Designation from the US FDA for our pTau217/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 and General Manager, Clinical Chemistry and Immunoassay for Beckman Coulter Diagnostics, said in a press release.
The FDA’s Breakthrough Device Designation program is intended to expedite the development and review of medical devices that provide significant advancements in diagnosing or treating life-threatening or irreversibly debilitating conditions. The designation offers prioritized review and regulatory support, aiming to bring innovative devices to market more efficiently.
Beckman Coulter is developing a suite of neurodegenerative disease tests. The company notes the aging global population and emerging drug treatments are expected to increase demand for AD testing, requiring accurate, high-throughput assays. They state that the Beckman Coulter DxI 9000 Immunoassay Analyzer and Lumi-Phos PRO substrate have enabled the development of precise assays capable of detecting neurological biomarkers on an automated, high-throughput platform.
FDA Approves Esketamine as Monotherapy for Adults With Treatment-Resistant Depression
January 21st 2025The approval of esketamine follows an FDA Priority Review and is based on data showing that esketamine alone demonstrated rapid and superior improvement in depressive symptoms compared with placebo.
