Aug. 24, 2026—The Food and Drug Administration has cleared Roche’s Elecsys Phospho-Tau (217P) Plasma (pTau217) blood test, to aid in identifying amyloid pathology associated with Alzheimer’s disease in people 55 years and older with signs, symptoms, or complaints of cognitive decline.
Developed in collaboration with Eli Lilly and Company, the assay is the first FDA-cleared, single-biomarker blood test that supports rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings. The test provides positive, intermediate, and negative result categories to support assessment of the likelihood of amyloid pathology. Results are interpreted in conjunction with clinical information and other relevant findings as part of the Alzheimer’s disease diagnostic pathway.
The test is designed for use on Roche’s Cobas instruments.