SMDx Detect™ p-Tau217
SMDx Detect™ p-Tau217 is a high-performance proprietary monoclonal antibody developed by SMarT Minds Dx for the sensitive detection and quantification of phosphorylated tau at threonine-217 (pThr217) in human plasma, cerebrospinal fluid (CSF), and tissue. The signal specificity of SMDx Detect™ p-Tau217 is shown in Fig.1.
Of all blood-based biomarkers, p-Tau217 shows the strongest single biomarker correlation with amyloid-positive status confirmed by PET imaging or CSF 1 and is a biomarker in US FDA cleared tests2.
The 2024 revised criteria by the Alzheimer’s Association Workgroup explicitly name plasma p-Tau217 as a Core 1 biomarker meaning a positive result from an accurate p-Tau217 assay is sufficient for a biological diagnosis of AD, with or without imaging confirmation (Jack et al., Alzheimer’s & Dementia 2024).
Ordering information
Validated on Quanterix Simoa HD-X and compatible with leading immunoassay and mass spectrometry platforms
Broad compatibility for research and translational use across sample matrices
Designated as a Core 1 T-biomarker in the 2024 Alzheimer’s Association revised diagnostic and staging criteria
Validated use case Demonstrated utility for monitoring response to amyloid-depleting disease-modifying treatments including Leqembi (lecanemab) and Kisunla (donanemab)
References
References:
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- Ashton, N.J., Brum, W.S., Di Molfetta, G., Benedet, A.L., Arslan, B., Jonaitis, E., Langhough, R.E., Cody, K., Wilson, R., Carlsson, C.M. and Vanmechelen, E., 2024. Diagnostic accuracy of a plasma phosphorylated tau 217 immunoassay for Alzheimer disease pathology. JAMA neurology, 81(3), pp.255-263.
- https://www.fda.gov/news-events/press-announcements/fda-clears-first-blood-test-used-diagnosing-alzheimers-disease (Accessed on 29/10/2026)