Elecsys® pTau217 – Alzheimer’s Disease (AD)

Aid in identifying AD by the diagnosis of amyloid pathology

Alzheimer wave and new therapies

Why early, blood-based detection matters

Alzheimer’s disease is becoming an increasing healthcare challenge as populations age. An estimated 75% of people living with dementia remain undiagnosed globally,* while the diagnostic pathway currently takes around 3.5 years on average.¹ With disease-modifying therapies now available and more in development, timely and accurate assessment is becoming increasingly important.

Amyloid accumulation and tau hyperphosphorylation can begin years before clinical symptoms appear. Until recently, confirming amyloid pathology relied on lumbar puncture or amyloid PET, approaches that can be invasive, costly or limited to specialised centres and are difficult to scale to a growing patient population.*

*1. Alzheimer’s Disease International. Dementia statistics.
2.Roche. Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® pTau217. Media release, 12 May 2026.



pTau test

Plasma pTau217

A new approach to Alzheimer’s-related cognitive decline

A single routine blood test provides a biomarker-based approach to assessing cognitive decline associated with Alzheimer’s disease, supporting clinical decision-making in primary and specialty care and helping identify patients who may benefit from further diagnostic evaluation and specialist referral.

CE-IVDR certified

Early detection of amyloid pathology enables…

Earlier, targeted specialist referral

Resulting in less diagnostic uncertainty for patients and families

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 results

pTau test

Patients ≥55 years with cognitive decline

The pathway begins with patients aged 55 years and older who present with cognitive decline. Following clinical assessment and blood collection, a routine blood sample can be used to support the next step in the diagnostic process.

pTau test

Quantitative blood testing with Elecsys® pTau217

Elecsys® pTau217 quantitatively measures phosphorylated tau 217 in plasma using the fully automated Roche cobas® platform. The result is interpreted against defined cut-offs to determine the likelihood of amyloid pathology.

pTau test

Clear result categories to guide action

Elecsys® pTau217 results are categorised into three likelihood groups for amyloid pathology: high, intermediate and low.

High likelihood
High likelihood of amyloid pathology.
→ Consider targeted specialist evaluation and further diagnostic assessment where appropriate.

Intermediate likelihood
Result remains inconclusive.
→ Further assessment, such as CSF biomarkers or amyloid PET, may be needed.

Low likelihood
Low likelihood of amyloid pathology.
→ Consider other potential causes of cognitive decline and avoid unnecessary specialist referral where appropriate.

Results should always be interpreted in the context of the patient’s overall clinical presentation and other relevant diagnostic findings.

Key facts at a glance

Elecsys® pTau217 combines a simple plasma sample requirement with strong clinical performance to support the assessment of amyloid pathology in patients with cognitive decline.¹˒⁴

1 x K2-EDTA

Minimally invasive plasma test – a routine blood draw, scalable to every patient in your practice

98.6%¹

Sensitivity in cognitively impaired patients (PET-confirmed, primary care)

90.2%¹

Positive predictive value (PPV) at upper cutoff in cognitively impaired patients (PET-confirmed, secondary care)

<6%⁴

Indeterminate results

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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 published³–⁵.

  • 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.


Healthcare professionals involved in the assessment of patients with cognitive decline, including primary and secondary care physicians, neurologists and memory clinics.

1× standard plasma tube (K2-EDTA)

Quantitative electrochemiluminescence immunoassay (ECLIA), Roche cobas®

Currently once per week, with frequency to increase based 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.