Earlier, targeted specialist referral
Resulting in less diagnostic uncertainty for patients and families
Plasma pTau217
A new approach to assessing cognitive decline associated with Alzheimer’s disease
A single routine blood sample provides a biomarker-based answer in primary and specialty care – before deciding who needs further referral.
CE-IVDR certified
Early detection of amyloid pathology enables…
Timely access to disease-modifying therapies
where clinically indicated (e.g. donanemab, approved in Switzerland) – with ApoE ε4 status known
Fewer unnecessary invasive tests
Leaving CSF/PET only for those who need them for further confirmatory testing, if deemed necessary by the clinician*
Earlier care planning, cognitive support therapy
and counselling for patients and relatives
How it works: from blood draw to actionable result
Diagnostic Pathway
Patients ≥55 years with cognitive decline
How it works: from blood draw to actionable result
Minimally invasive
Clinical assessment & blood collection
Sample type: routineblood sample
How it works: from blood draw to actionable result
Efficient workflow
Elecsys® pTau217 quantitative blood test
"Clear result categories: high, intermediate or low likelihood of amyloid pathology."
How it works: from blood draw to actionable result
Targeted, actionable results
One analyte, three result categories – low, intermediate, high likelihood of amyloid pathology – so you can rule out, rule in, or direct only the small indeterminate group to further testing.
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Performance you can rely on
Published data from five independent clinical cohorts (n = 538), in a cognitively impaired population, amyloid PET served as reference standard:*
1 x K2-EDTA
Minimally invasive plasma test – a routine blood draw, scalable to every patient in your practice
98.6%*
Sensitivity in cognitively impaired patients (PET-confirmed, primary care)
90.2%*
Positive predictive value (PPV) at upper cutoff in cognitively impaired patients (PET-confirmed, secondary care)
<6%*
Indeterminate results
Supporting the assessment of Alzheimer’s disease in patients with cognitive decline
Elecsys® pTau217 accurately detects amyloid-positivity in unselected cohorts, and fewer than 6% of results fall into the intermediate (grey) zone
Plasma pTau181 can offer a useful negative predictive value, but an elevated pTau181 is not indicative of amyloid pathology*. pTau217 reflects amyloid burden much more closely and supports a dual-cutoff read-out that works in both directions: reliable rule-out and rule-in*. ApoE ε4: A genetic result that guides therapy ApoE ε4 status determination is mandatory prior to anti-amyloid treatment; homozygous carriers have a markedly higher ARIA risk (contraindication).
Combined with pTau217, ApoE ε4 raises discrimination to AUC 0.970 (from 0.939; p = 0.02)5 in a memory-clinic cohort.
A positive Elecsys® pTau217 result does not by itself establish a diagnosis of Alzheimer’s disease. Results must be interpreted together with the full clinical picture, including cognitive assessment, neuroimaging and the patients’ clinical history.
For patients ≥ 55 years with signs, symptoms or complaints of cognitive decline associated with Alzheimer’s disease
Elecsys® pTau217 is the first blood test for Alzheimer’s disease pathology with a single-assay design – offering accuracy comparable to spinal-fluid testing via one routine blood draw, and turning a diagnostic pathway that today takes 3.5 years on average into a quick, actionable result1.
It works as a first-line triage tool: in the clinical practice cohort, plasma pTau217 showed high concordance with amyloid PET (AUC0.933), with fewer than 6%of results in the indeterminate zone needing confirmatory CSF or PET testing.
Elecsys® pTau217 – Alzheimer’s Disease (AD)
Adding clinical value to the assessment of cognitive decline
Narrow grey zone in unselected cohorts fewer than 6% of results are intermediate4. This means that only a targeted minority needs CSF/PET. One avoided confirmatory workup outweighs the price of the test.
Ruleout and rule-in with a dual cutoff, not just exclusion
Transparent evidence: cutoffs and the selected control population are published*.
Fully automated, standardised Roche cobas® platform; CEIVDR certified.
Practical information & ordering
Rule-in or rule-out of amyloid pathology in individuals ≥ 55 years with signs or symptoms of cognitive decline. Not intended for screening of asymptomatic individuals.
Primary and secondary care physicians, neurologists, memory clinics
1× standard plasma tube (K2-EDTA)
Quantitative electrochemiluminescence immunoassay (ECLIA), Roche cobas®
1x per week, to be further increased depending on demand
CHF 85*
* Currently not covered by mandatory health insurance (OKP)
References
1. Roche.Elecsys® pTau217 plasma phosphorylated-tau 217: CE mark media release.12 May 2026. 2. Ritchie C, et al.Elecsys pT181p immunoassay: Clinical performance for ruling out amyloid pathology.Alzheimer’s Dement. 2026;18(3):e70439. doi:10.1002/dad2.70439.
3. Hibar DP, et al.Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts.Alzheimer’s Dement. 2026;22(1). doi:10.1002/alz.71009.
4. Hortsch S, et al.Performance of a fully automated plasma p-tau217 immunoassay to reflect amyloid-beta burden in clinical practice.J Prev Alzheimers Dis. 2026;13(5):100534. doi:10.1016/j.tjpad.2026.100534.
5. Titeca J, et al.Automated high-throughput quantification of plasma p-tau217 and APOE-ε4 in a memory cohort.Alzheimers Res Ther. 2026;18(1):99.
Fig. 1: Adapted conceptually from Salvadó G, et al.Disease staging of Alzheimer’s disease using a CSF- based biomarker model.Nat Aging. 2024;4:694–708. doi:10.1038/s43587-024-00599-y.
Fig. 2: Adapted conceptually from Brum WS, et al.A two-step workflow based on plasma p-tau217 to screen for amyloidβ positivity.Nat Aging. 2023;3:1079–1090.