FDA puts breakthrough tag on Roche, Lilly Alzheimer’s test

April 11, 2024


The pTau217 plasma biomarker test, which runs on Roche’s widely-used Elecsys analysers, is intended to look for the presence or absence of amyloid pathology in individuals with suspected Alzheimer’s.

pTau217 is a phosphorylated fragment of the protein tau that in research studies has been shown to distinguish Alzheimer’s from other neurodegenerative disorders, and potentially to detect elevated risk of the disease years before symptoms develop.

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