Quanterix Submits FDA 510(k) for Alzheimer’s Blood Test
Event summary
- Quanterix submitted a 510(k) premarket notification to the FDA for a multi-analyte algorithmic blood test for Alzheimer’s disease detection.
- The test uses Simoa® technology to measure five key analytes: p-Tau 217, Aβ42, Aβ40, GFAP, and NfL.
- The submission is supported by clinical evidence from over 1,800 symptomatic patients across three independent cohorts.
- Quanterix previously received Breakthrough Device Designation from the FDA for this test.
The big picture
Quanterix’s FDA submission marks a critical step in advancing non-invasive Alzheimer’s diagnostics, aligning with the growing demand for early detection tools. The company’s acquisition of Akoya Biosciences in 2025 further strengthens its position by integrating spatial biology with its existing biomarker detection capabilities. This strategic move positions Quanterix to capitalize on the emerging class of disease-modifying therapies for Alzheimer’s.
What we're watching
- Regulatory Approval
- The pace at which the FDA reviews and approves the 510(k) submission will determine the test’s market availability.
- Market Adoption
- Whether the multi-analyte approach can gain traction among clinicians and patients seeking non-invasive Alzheimer’s detection.
- Competitive Positioning
- How Quanterix’s integrated platform of blood and tissue diagnostics will differentiate it from competitors in the Alzheimer’s diagnostic space.
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