Quanterix Submits FDA 510(k) for Multi-Analyte Blood Test to Detect Alzheimer's Disease

Quanterix has submitted a 510(k) premarket notification to the FDA for a multi-analyte blood test for Alzheimer's disease detection. The test, which utilizes Simoa technology, measures a panel of five key analytes to aid in identifying patients with cognitive symptoms who are likely to have amyloid brain plaques, a hallmark of Alzheimer's disease. The submission is supported by extensive clinical evidence and represents a significant milestone in Quanterix's mission to provide superior diagnostic tools for Alzheimer's disease.