The test uses five biomarkers and proprietary technology to detect amyloid brain plaques in patients with cognitive symptoms.
Quanterix Corp has submitted a 510(k) premarket notification to the US Food and Drug Administration (FDA) for a multi-analyte algorithmic blood test designed to aid in Alzheimer’s disease detection. The test previously received Breakthrough Device Designation from the FDA.
The blood test is intended to help identify whether patients with cognitive symptoms are likely to have amyloid brain plaques, a hallmark of Alzheimer’s disease. The test provides diagnostic information through a non-invasive blood draw rather than more invasive procedures.
The multi-analyte test uses Quanterix’s proprietary Simoa technology to measure five key analytes: p-Tau 217, Aβ42, Aβ40, GFAP, and NfL. By integrating these biomarkers of amyloid pathology, tau pathology, neuroinflammation, and axonal damage into a single algorithmic result, the test aims to provide a more complete assessment than single-analyte assays.
“Both research and extensive clinical validation evidence confirm that a multi-analyte panel is essential for capturing the complexity and trajectory of this disease,” says Mike Miller, chief operating officer of Quanterix, in a release. “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.”
Clinical Evidence and Technology
The submission is supported by clinical evidence 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, addressing sensitivity limitations often found in conventional analog immunoassay methods and mass spectrometry. The inclusion of multiplexed GFAP and NfL can enable potential differential and prognostic insights, extending patient risk evaluations beyond amyloid status readout provided by p-Tau 217 and ratio tests.
The multi-analyte approach is designed to improve diagnostic clarity, particularly in early stages of disease progression where single-analyte levels can often fall into an intermediate or inconclusive range.
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