Earlier, targeted specialist referral
Resulting in less diagnostic uncertainty for patients and families
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.*
*Alzheimer’s Disease International. Dementia statistics.
1. Roche. Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys® pTau217. Media release, 12 May 2026.
Plasma pTau217
A new approach to assessing patients with signs of 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
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 pathology2. pTau217 reflects amyloid burden much more closely and supports a dual-cutoff read-out that works in both directions: reliable rule-out and rule-in2-4. 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 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.
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)