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Roche gets second European approval for Alzheimer's test
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Roche gets second European approval for Alzheimer's test
May 11, 2026 10:21 PM

ZURICH, May 12 (Reuters) - Swiss drugmaker Roche

has received the CE mark - a European regulatory

clearance allowing sale in the region - for its second Elecsys

blood test for Alzheimer's disease, it said on Tuesday.

The test was developed with U.S. company Eli Lilly ( LLY ).

* Compared with its already approved pTau181 test, which

mainly helps rule out Alzheimer's-related amyloid pathology, the

newer pTau217 test can both help confirm and exclude the

disease. It is validated for use in both primary and specialist

care.

* The test has already received breakthrough device

designation from the U.S. FDA.

* Blood tests could speed diagnosis and widen access to

treatments such as Biogen and Eisai's ( ESALF ) Leqembi

and Eli Lilly's ( LLY ) Kisunla, as current diagnostic methods are often

costly or uncomfortable.

* Roche said an estimated 75% of people living with dementia

remain undiagnosed.

* The test is expected to become available in CE-marked

markets from July, Olivier Gillieron, life cycle leader in

cardiometabolic and neurology at Roche told media in a call.

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