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EAN 2025 | Reflecting on the recent FDA approval of the first blood-based diagnostic test for AD

Giulia Giacomucci, MD, University of Florence, Florence, Italy, reflects on the recent FDA approval of the first blood-based diagnostic test for Alzheimer’s disease (AD). Dr Giacomucci comments on how this will impact clinical practice and patient outcomes, and hopes that the EMA will also approve this test, allowing for its use in Europe. This interview took place at the 11th Congress of the European Academy of Neurology (EAN 2025) in Helsinki, Finland.

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Transcript

The recent approval by the FDA of the commercial tool by Fujirebio of the plasma p-tau217 and Aβ42 ratio drastically changed this scenario of Alzheimer’s disease. Indeed, now the FDA had approved the use of this commercial tool for diagnostic purposes. We are waiting for the EMA but we hope that this change will be also transferred to Europe and maybe to Italy or in general to Europe. With this approval now the use of plasma biomarkers is becoming reality and it could be extremely interesting to use them in clinical practice because it may represent the first step for the clinical diagnosis of Alzheimer’s disease...

The recent approval by the FDA of the commercial tool by Fujirebio of the plasma p-tau217 and Aβ42 ratio drastically changed this scenario of Alzheimer’s disease. Indeed, now the FDA had approved the use of this commercial tool for diagnostic purposes. We are waiting for the EMA but we hope that this change will be also transferred to Europe and maybe to Italy or in general to Europe. With this approval now the use of plasma biomarkers is becoming reality and it could be extremely interesting to use them in clinical practice because it may represent the first step for the clinical diagnosis of Alzheimer’s disease. Maybe the plasma biomarkers use should be included in the diagnostic algorithm probably as a first step so patients who refer cognitive decline or cognitive symptoms may undergo the plasma biomarkers analysis and then according to the specific cutoff that should be validated, obviously, they may be divided according to the real risk of having an underlying Alzheimer’s disease pathology. So it could completely change the diagnostic process of Alzheimer’s disease.

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