FDA clears pTau217 blood test for Alzheimer's disease
MDSpire News
August 24, 2026
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The FDA has cleared the Elecsys Phospho-Tau (217P) Plasma blood test for identifying amyloid pathology in Alzheimer's disease.
The test is intended for patients aged 55 and older with cognitive decline symptoms and provides classifications of positive, intermediate, or negative.
Elecsys pTau217 was developed in collaboration with Eli Lilly and Company and shows high concordance with amyloid PET imaging results.
The assay can be integrated into existing laboratory workflows on Roche cobas instruments without additional equipment.
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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