The FDA cleared a new blood test for Alzheimer’s from Roche and Eli Lilly, aimed at ruling in and ruling out amyloid pathology using phosphorylated tau 217 (pTau217) levels. Roche’s Elecsys pTau217 assay, already cleared in Europe, is designed for people age 55 and older with signs of cognitive decline. Labcorp and Quest Diagnostics said they plan to offer the test, positioning the assay for broad access beyond specialty centers. The clearance adds to momentum from earlier FDA decisions on blood-based tau/amyloid tests, including Fujirebio’s Lumipulse in 2025 and C2N Diagnostics’ PrecivityAD2. Analysts framed the new launch as a signal of rising competition in Alzheimer’s blood diagnostics, with assay standardization and instrument compatibility emerging as differentiators. Roche said the test uses validated clinical cutoffs across settings and is built for Cobas lab systems.