Roche announces that its Elecsys pTau217 test, developed in collaboration with Eli Lilly, has received breakthrough device designation from the U.S. FDA, to support the early diagnosis of Alzheimer's disease.

This blood test will be used to help identify in individuals the presence or absence of amyloid pathology, a key feature of this disease, which can help ensure that patients are able to receive appropriate care.

As a reminder, the designation is designed to speed up the development and review of certain medical devices. If approved, the test could thus contribute to rapidly expanding access to faster, more accurate diagnosis of Alzheimer's disease.

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