Earlier, targeted specialist referral
Resulting in less diagnostic uncertainty for patients and families
Alzheimer wave and new therapies
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.
Plasma pTau217
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
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
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.
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.
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.
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
Elecsys® pTau217 offers a minimally invasive, blood-based assessment of amyloid pathology in patients with cognitive decline. With fewer than 6% of results falling into the intermediate zone⁴ in the referenced cohort, most patients can be classified as having a low or high likelihood of amyloid pathology.
A narrow intermediate zone means fewer inconclusive results. This supports clearer clinical decision-making and helps limit additional CSF or amyloid PET testing to the smaller group of patients who still require further clarification.
Plasma pTau181 can offer a useful negative predictive value, but an elevated pTau181 is not indicative of amyloid pathology². pTau217 reflects amyloid burden more closely and supports a dual-cutoff read-out that works in both directions: reliable rule-out and rule-in.
ApoE ε4 status determination is mandatory prior to anti-amyloid treatment. Homozygous carriers have a markedly higher risk of ARIA (amyloid-related imaging abnormalities), which is clinically relevant for treatment decisions.
Combined with pTau217, ApoE ε4 further improves discrimination to an AUC of 0.970 (from 0.939; p = 0.02)⁵ in a memory-clinic cohort.
A positive result indicates a high likelihood of amyloid pathology. It should be interpreted together with the patient’s clinical assessment, cognitive testing, neuroimaging and clinical history, and may support further specialist evaluation or confirmatory testing where appropriate.
A positive result does not by itself establish a diagnosis of Alzheimer’s disease.
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)
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.
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.