Quanterix Seeks FDA Clearance for Groundbreaking Alzheimer’s Blood Test

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Biotechnology firm Quanterix has taken a pivotal step toward transforming the diagnosis of Alzheimer’s disease. The company has formally submitted an application to the U.S. Food and Drug Administration (FDA) for a novel blood test, bringing the potential for a commercially available, non-invasive diagnostic tool significantly closer to reality.

The submission, filed on Thursday, February 5, 2026, is a 510(k) application for the company’s multi-analyte blood test. This diagnostic leverages Quanterix’s proprietary Simoa technology to detect and measure five key biomarkers associated with neurodegeneration: p-Tau 217, Aβ42, Aβ40, GFAP, and NfL.