Quanterix Corporation, a company transforming healthcare by accelerating biomarker breakthroughs from discovery to diagnostics, announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for a multi-analyte algorithmic blood test for Alzheimer’s disease (AD). This submission represents a significant milestone in the Company’s mission to provide superior, non-invasive, high-performance diagnostic tools to aid in the evaluation of patients with cognitive symptoms for possible AD. 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, providing diagnostic clarity through a non-invasive blood test. 

The multi-analyte algorithmic blood test utilises Quanterix’s proprietary Simoa technology to measure a panel of five key analytes: p-Tau 217, Aβ42, Aβ40, GFAP, and NfL. By integrating these AD-relevant biomarkers of amyloid pathology, tau pathology, neuroinflammation, and axonal damage into a single algorithmic result, the test provides a more comprehensive assessment of the biological drivers of Alzheimer’s disease than single-analyte assays. This multi-analyte approach is designed to improve diagnostic clarity, particularly in the early stages of disease progression, where single-analyte levels can often fall into an "intermediate" or inconclusive range. 

The submission is supported by extensive clinical evidence recently published in Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring, spanning three independent cohorts and over 1,800 symptomatic patients. Simoa digital sensitivity enables a quantitative test result for every patient, overcoming the sensitivity limitations often found in conventional analogue immunoassay methods and mass spectrometry. Furthermore, the unique inclusion of multiplexed GFAP and NfL can enable potential differential and prognostic insights, extending patient risk evaluations beyond a static amyloid status readout as provided by p-Tau 217 and ratio tests. 

“The strong execution of the Quanterix team has resulted in this submission, a watershed moment for Quanterix and millions of families seeking clearer answers in the fight against Alzheimer’s Disease,” said Mike Miller, Chief Operating Officer of Quanterix. Both research and extensive clinical validation evidence confirm that a comprehensive, multi-analyte panel is essential for capturing the complexity and trajectory of this disease. This filing is the next step in our strategy to establish our technology as a gold standard in clinical diagnostics, offering a scalable solution that bridges the gap between early detection and the emerging class of disease-modifying therapies.”