Roche Wins EU CE Mark for pTau 217 Blood Test, Aiding Alzheimer’s Triage
Updated
Updated · AD HOC NEWS · Jun 27
Roche Wins EU CE Mark for pTau 217 Blood Test, Aiding Alzheimer’s Triage
1 articles · Updated · AD HOC NEWS · Jun 27
Summary
CE marking now allows Roche’s Elecsys pTau 217 plasma assay to be used across EU and EEA markets as part of Alzheimer’s diagnostic workups.
The test measures phosphorylated tau 217 to help rule in or rule out amyloid pathology, giving clinicians a blood-draw option instead of relying first on lumbar punctures or PET scans.
Roche says the assay runs on its existing Elecsys immunoassay platforms, letting routine labs process higher volumes and easing bottlenecks where advanced imaging capacity is limited.
Co-developed with Eli Lilly, the assay is positioned as a triage tool for identifying patients who may need confirmatory testing and could qualify for emerging anti-amyloid therapies.
Uptake will still depend on real-world performance, reimbursement and guideline adoption, since the blood test is not a standalone Alzheimer’s diagnosis.
This new Alzheimer's test is a breakthrough, but will insurance and cost hurdles prevent patients from accessing it?
As giants like Roche and Abbott race to market, who will win the billion-dollar Alzheimer's blood test war?
With blood tests predicting Alzheimer's years early, are we creating a generation of anxious 'patients-in-waiting'?
90% Accurate Blood Test for Alzheimer’s: Roche’s Elecsys pTau217 Receives CE Mark, Launches Across Europe
Overview
Roche Holding AG, in collaboration with Eli Lilly and Co., has achieved CE mark approval for its Elecsys plasma phosphorylated-tau 217 (pTau217) blood test, making it immediately available across Europe. This innovative test allows clinicians to confirm or exclude amyloid pathology, a key indicator of Alzheimer’s disease, using a simple blood sample. By offering a more accessible and less invasive alternative to traditional brain scans, the Elecsys pTau217 test significantly improves the accuracy and ease of Alzheimer’s diagnosis, helping healthcare providers identify and support patients more efficiently throughout the European healthcare system.