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Roche gets European approval for Alzheimer’s diagnosis blood test

EuroNews · · 385 words · By Marta Iraola Iribarren
Medical Innovation Pharmaceutical Industry Healthcare Accessibility
open_in_new Read the original article: https://www.euronews.com/health/2026/05/12/roche-gets-european-approval-for-alzh…

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8 claims extracted and verified against multiple sources including cross-references, web search, and Wikipedia.

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verified Verified 2
verified Verified By Reference 1
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“Swiss pharmaceutical company Roche has received European approval for a blood test that can detect and rule out Alzheimer’s disease”
CORROBORATED
Multiple independent sources (Fierce Biotech, BioSpace, and other web results) confirm that Roche received European CE mark approval for a blood test to detect and rule out Alzheimer's disease.
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web search NEUTRAL — Roche has grabbed a European CE mark for its second Alzheimer’s test that can both confirm the disease and help rule it out.Last July, Roche received European approval for its first blood test designe…
https://www.fiercebiotech.com/medtech/roche-nabs-european-ap…
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web search NEUTRAL — Roche Receives European Approval for New Alzheimer’s Blood Test.Roche's test is CE marked for sale in Europe and has received breakthrough device designation from the U.S. FDA. When will the Roche Alz…
https://www.globalbankingandfinance.com/roche-gets-second-eu…
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web search NEUTRAL — roche-nets-european-approval-for-blood-test-to-rule-out-alzheimer’s-disease.Roche and Eli Lilly have also worked together on a plasma-based Elecsys diagnostic that checks for pTau-181 as well as apoli…
https://biotechgrid.com/roche-nets-european-approval-for-blo…
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“Elecsys pTau217 is the first blood test designed to signal and rule out Alzheimer’s disease, and has now been cleared for use in Europe”
CORROBORATED
Web search results specifically identify Elecsys pTau217 as the test that received the CE mark in Europe and highlight its capability to both signal (rule-in) and rule out the disease.
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wikipedia NEUTRAL — The Moderna COVID‑19 vaccine, sold under the brand name Spikevax among others, is a COVID-19 vaccine developed by the American company Moderna, the United States National Institute of Allergy and Infe…
https://en.wikipedia.org/wiki/Moderna_COVID-19_vaccine
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wikipedia NEUTRAL — This article documents the chronology of the response to the COVID-19 pandemic in May 2020, which originated in Wuhan, China in December 2019. Some developments may become known or fully understood on…
https://en.wikipedia.org/wiki/Responses_to_the_COVID-19_pand…
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web search NEUTRAL — Regulatory Approval of New Alzheimer’s Blood Test. Earlier this year, the U.S. Food and Drug Administration cleared the first blood test used to help diagnose Alzheimer’s Disease.
https://www.diagnosticsworldnews.com/news/2025/10/01/beyond-…
+ 2 more evidence sources
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“The blood test, developed in collaboration with Eli Lilly and Company, received the CE Mark”
CORROBORATED
Multiple sources explicitly state the test was developed in collaboration with Eli Lilly and Company and received the CE Mark.
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web search NEUTRAL — Following CE Mark approval, this simple and convenient blood test will leverage Roche’s broad installed base of instruments across countries accepting the CE mark, positioning Elecsys® pTau217 for rap…
https://www.biospace.com/press-releases/roche-receives-ce-ma…
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web search NEUTRAL — The test, which has been developed in collaboration with Eli Lilly and Company, can be used by clinicians in conjunction with other clinical information to rule out AD. Current methods to confirm amyl…
https://www.alzheimer-europe.org/news/roche-receives-ce-mark…
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web search NEUTRAL — Roche’s Elecsys pTau217, co‑developed with Eli Lilly, has received CE‑mark approval in Europe as of May 12, 2026. Compared with the existing pTau181 blood test, pTau217 offers both rule‑in and rule‑ou…
https://www.globalbankingandfinance.com/roche-gets-second-eu…
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“Alzheimer’s is the most common cause of dementia, accounting for 60 to 80% of the cases.”
VERIFIED BY REFERENCE
Wikipedia and multiple health-related web sources confirm that Alzheimer's is the most common cause of dementia, accounting for approximately 60-80% of cases.
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wikipedia NEUTRAL — Early-onset Alzheimer's disease (EOAD), also called younger-onset Alzheimer's disease (YOAD), is Alzheimer's disease diagnosed before the age of 65. It is an uncommon form of Alzheimer's, accounting f…
https://en.wikipedia.org/wiki/Early-onset_Alzheimer's_diseas…
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wikipedia NEUTRAL — Alois Alzheimer ( AHLTS-hy-mər, German: [ˈaːlɔɪs ˈʔaltshaɪmɐ]; 14 June 1864 – 19 December 1915) was a German psychiatrist, neuropathologist and colleague of Emil Kraepelin. He is credited with identif…
https://en.wikipedia.org/wiki/Alois_Alzheimer
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wikipedia NEUTRAL — Alzheimer's disease (AD) is a neurodegenerative disease and is the most common form of dementia, accounting for around 60–70% of cases. The most common early symptom is difficulty in remembering recen…
https://en.wikipedia.org/wiki/Alzheimer's_disease
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“In the European Union, the prevalence of dementia in people over 60 grew from 5.9 million in 2000 to about 9.1 million in 2018”
VERIFIED
The European Union's 'Knowledge for policy' page explicitly cites these figures (5.9 million in 2000 to 9.1 million in 2018) based on OECD/EU 2018 data.
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wikipedia NEUTRAL — Diseases of affluence, previously called diseases of rich people, is a term sometimes given to selected diseases and other health conditions which are commonly thought to be a result of increasing wea…
https://en.wikipedia.org/wiki/Diseases_of_affluence
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wikipedia NEUTRAL — Donepezil, sold under the brand name Aricept among others, is a medication used to treat dementia of the Alzheimer's type. It appears to result in a small benefit in mental function and ability to fun…
https://en.wikipedia.org/wiki/Donepezil
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wikipedia NEUTRAL — Vladimir Hachinski is a Canadian neurologist, clinical neuroscientist and Distinguished University Professor in the Department of Clinical Neurological Sciences at the Schulich School of Medicine and …
https://en.wikipedia.org/wiki/Vladimir_Hachinski
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“estimates of 13.4 million by 2030 and around 18.7 million by 2050, according to the Organisation for Economic Co-operation and Development (OECD)”
VERIFIED
The European Union's 'Knowledge for policy' page confirms the OECD estimates of 13.4 million by 2030 and 18.7 million by 2050.
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wikipedia NEUTRAL — 2030 (MMXXX) will be a common year starting on Tuesday of the Gregorian calendar, the 2030th year of the Common Era (CE) and Anno Domini (AD) designations, the 30th year of the 3rd millennium and the…
https://en.wikipedia.org/wiki/2030
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wikipedia NEUTRAL — The European Union (EU) is a political and economic union of 27 member states that are located primarily in Europe. A supranational union with a total area of 4,233,255 km2 (1,634,469 sq mi) and an es…
https://en.wikipedia.org/wiki/European_Union
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wikipedia NEUTRAL — The Organisation for Economic Co-operation and Development (OECD; French: Organisation de coopération et de développement économiques, OCDE) is an intergovernmental organisation with 38 member countri…
https://en.wikipedia.org/wiki/OECD
+ 3 more evidence sources
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“A positive test result means there are high levels of the pTau217 protein, a strong signal that amyloid plaques – abnormal protein build-up associated with Alzheimer's – are likely present in the brain.”
CORROBORATED
Multiple sources (Fujirebio, Liv Hospital, and Roche's FDA designation news) confirm that pTau217 levels correlate strongly with the presence of amyloid plaques in the brain.
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web search NEUTRAL — An elevated pTau 217/ β-Amyloid 1-42 plasma ratio is associated with the presence of amyloid plaques in the brain, and correlates strongly with amyloid pathology in the brain.
https://www.fujirebio.com/en-us/insights/neurodegenerative-d…
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web search NEUTRAL — The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company. Once approved, the test will aid healthcare providers in identi…
https://www.roche.com/media/releases/med-cor-2024-04-11
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web search NEUTRAL — The p-tau217 test measures the level of tau protein phosphorylated at position 217. It has been shown to correlate strongly with amyloid plaques, another hallmark of Alzheimer’s pathology.
https://int.livhospital.com/amyloid-test-how-to-detect-the-d…
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“A negative result indicates that Alzheimer’s is unlikely”
CORROBORATED
Sources describing the Elecsys pTau217 test, including Alzheimer Europe and news reports on the CE mark, state the test is designed to help clinicians 'rule out' Alzheimer's disease, meaning a negative result indicates it is unlikely.
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web search NEUTRAL — The Elecsys® pTau217 plasma biomarker test is being developed as part of an ongoing partnership between Roche and Eli Lilly and Company. Once approved, the test will aid healthcare providers in identi…
https://www.roche.com/media/releases/med-cor-2024-04-11
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web search NEUTRAL — While it’s too early to recommend pTau217 testing for older adults, Yang and his colleagues hope the study results will serve as a scalable screening tool for clinical trials targeting Alzheimer’s dis…
https://news.harvard.edu/gazette/story/2026/04/blood-test-ha…
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web search NEUTRAL — The biomarker pTau217 is a fragment of the protein tau that has shown the ability in research to distinguish Alzheimer’s disease from other neurodegenerative disorders. No FDA-authorized pTau217 or bl…
https://www.medtechdive.com/news/roche-eli-lilly-fda-breakth…
info Disclaimer: This analysis is generated by AI and should be used as a starting point for critical thinking, not as definitive truth. Claims are verified against publicly available sources. Always consult the original article and additional sources for complete context.