Quanterix Submits 510(k) Premarket Notification to FDA For Multi-Analyte Algorithmic Blood Test For Alzheimer's Disease

The multi-analyte test previously received Breakthrough Device Designation from the FDA, a program intended to accelerate the development and review of devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases. The test is intended to aid in identifying whether patients with cognitive symptoms are likely to have amyloid brain plaques—a hallmark of Alzheimer's disease—providing diagnostic clarity through a non-invasive blood test.