Roche and Eli Lilly have received FDA clearance for a new blood test, Elecsys pTau217, designed to help clinicians rule in and rule out Alzheimer’s disease. The assay measures phosphorylated tau 217 to assess amyloid plaque pathology earlier in the diagnostic pathway, and it is intended for use in people 55 and older with cognitive decline. The decision follows earlier biomarker momentum in the FDA-cleared blood-test space, including Fujirebio’s Lumipulse and other emerging in vitro tests. Roche said the product is built for use with its Cobas lab platform to support broader deployment outside specialty centers. Labcorp and Quest Diagnostics said they plan to offer the test, setting up a fresh competitive push among amyloid/tau blood diagnostics where consistent cutoffs and workflow integration are becoming central differentiators.