Shots:
- The US FDA has received 510(k) premarket notification for the multi-analyte algorithmic blood test to diagnose Alzheimer’s disease
- Submission was backed by data across three independent cohorts & 1,800+ pts, published in the Alzheimer’s & Dementia: Diagnosis, Assessment & Disease Monitoring
- The blood test uses Quanterix’s Simoa tech to integrate five AD biomarkers (p-Tau217, Aβ42, Aβ40, GFAP & NfL) into a single algorithmic readout, providing a more comprehensive & clearer early-stage Alzheimer’s assessment than single-analyte assays
Ref: Businesswire | Image: Quanterix | Press Release
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