FDA clears pTau217 blood test for Alzheimer's disease

The assay uses the same validated clinical cutoffs across primary and specialty care settings.

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The FDA has cleared the Elecsys Phospho-Tau (217P) Plasma blood test for identifying amyloid pathology in Alzheimer's disease.
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The test is intended for patients aged 55 and older with cognitive decline symptoms and provides classifications of positive, intermediate, or negative.
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Elecsys pTau217 was developed in collaboration with Eli Lilly and Company and shows high concordance with amyloid PET imaging results.
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The assay can be integrated into existing laboratory workflows on Roche cobas instruments without additional equipment.
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The test results should be used alongside other clinical information and are not established for predicting future dementia or tracking treatment responses.

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