The FDA cleared Roche and Eli Lilly’s Elecsys pTau217 plasma blood test for assessing both the likelihood of Alzheimer’s disease and the presence of amyloid pathology in patients with cognitive decline aged 55 and older. The assay is designed to support earlier placement in the diagnostic pathway, aiming to identify who should undergo further evaluation. The test joins a growing set of blood-based amyloid/tau assays entering U.S. practice. Roche said it designed the test for Cobas lab instruments to standardize clinical cutoffs across primary care and specialty settings, and Labcorp and Quest Diagnostics said they plan to offer it. Analysts characterized the launches as a competitive inflection point for Alzheimer’s diagnostics, with multiple platforms now vying for adoption in routine settings where PET and CSF are harder to scale.