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Elecsys® Phospho-Tau (217P) Plasma

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Alzheimer's Blood Test - ptau217

 

The power of one assay: Redefining Alzheimer’s diagnosis with Elecsys® Phospho-Tau (217P) Plasma1

Early and accurate diagnosis of Alzheimer's disease (AD) remains a significant global challenge. Up to 75% of individuals experiencing symptoms are not diagnosed, and those who do receive a diagnosis often face a delay of more than 2 years on average after symptom onset. The early and reliable identification of amyloid pathology is crucial for an accurate AD diagnosis and for guiding appropriate treatment.2,3

The Elecsys® pTau217 Plasma is a first standalone, clinically validated, IVD-cleared blood test with a unified dual-cut-off designed to rule-in and rule-out Alzheimer’s-associated amyloid pathology across settings.4

Traditional methods for confirming amyloid pathology, such as positron emission tomography (PET) scans can be expensive, difficult to access, and perceived as more invasive, the latter also mentioned for cerebrospinal fluid (CSF) assessments. The Elecsys® pTau217 Plasma assay is set to redefine this landscape by providing a minimally invasive, blood-based solution.

Benefits at a glance

Benefits at a glance

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References

  1. Chapleau M, et al. The role of amyloid PET in imaging neurodegenerative disorders. American Journal of Neuroradiology. 2022;43(6):813–825. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9165727/
  2. Update on Alzheimer’s diagnosis: focus on cerebrospinal fluid and blood-based biomarkers. MedizinOnline. 2024. Available at: https://medizinonline.com/en/update-on-alzheimers-diagnosis-focus-on-cerebrospinal-fluid-and-blood-based-biomarkers-2/
  3. Hortsch S, et al. Performance of a fully automated plasma tau phosphorylated at threonine 217 immunoassay to reflect amyloid‑beta burden in an unselected cohort representative of clinical practice. Journal of Prevention of Alzheimer’s Disease. 2026;13(5):100534. doi:10.1016/j.tjpad.2026.100534. Available at: https://www.sciencedirect.com/science/article/pii/S2274580726000580?via%3Dihub
  4. Hibar DP, et al. Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts. 2026. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12805464/
  5. Di Domenico A, Hortsch S, Jamal S, Caley D, Hodsdon M, Lu M, Knoll M. Evaluation of Elecsys Phospho‑Tau (217P) Plasma assay performance across care settings and cognitive statuses for Alzheimer’s disease diagnosis. Poster presented at: AD/PD 2026 – International Conference on Alzheimer’s and Parkinson’s Diseases; 17–21 March 2026; Copenhagen, Denmark (virtual/hybrid). Available at: https://medically.roche.com/global/en/neuroscience/adpd-2026/medical-material/ADPD-2026-poster-di-domenico-evaluation-of-elecsys-phospho-tau-217p-plasma-assay-performance-pdf.html
  6. Update on Alzheimer’s diagnosis: focus on cerebrospinal fluid and blood-based biomarkers. MedizinOnline. 2024. Available at: https://medizinonline.com/en/update-on-alzheimers-diagnosis-focus-on-cerebrospinal-fluid-and-blood-based-biomarkers-2/
  7. Burns JM, et al. Reimagining Care Delivery for Alzheimer Disease. JAMA Neurol. 2026. Avaiable from: https://jamanetwork.com/journals/jamaneurology/fullarticle/2847757
  8. Alzheimer’s Disease International. World Alzheimer Report 2022: Life after diagnosis: Navigating treatment, care and support [PDF; cited 2026 Apr 29]. Available from: https://www.alzint.org/u/World-Alzheimer-Report-2022.pdf.
  9. Alzheimer Europe. European Carers' Report 2018: Carers’ experiences of diagnosis in five European countries [PDF; cited 2026 Apr 29]. Available from: https://www.alzheimer-europe.org/sites/default/files/2021-11/04886%20Carers%27%20report_updated%20FINAL.pdf. 
  10. F. Hoffmann-La Roche Ltd. Elecsys pTau217 Method Sheet. (v1.0). 2026.
  11. Li Y, Lagier RJ, Racke MK and Fesko YA. Cost-effectiveness analysis of blood-based biomarker testing in the diagnosis of Alzheimer's disease pathology. J Prev Alzheimers Dis. 2026 Mar;13(3):100474. 
  12. Brum WS, et al. A two-step workflow based on plasma p-tau217 to screen for amyloid β positivity with further confirmatory testing only in uncertain cases. Nat Aging. 2023; 3:1079–1090. 
  13. Mattke S, et al. Estimation of the value-based price of a blood test for Alzheimer's disease pathology in primary and specialty care in the U.S. J Prev Alzheimers Dis. 2025 Aug;12(7):100219.