The Food and Drug Administration cleared Roche and Eli Lilly’s Elecsys pTau217 blood test for people aged 55 and older who have symptoms or complaints of cognitive impairment. The assay measures phosphorylated Tau 217, a biomarker associated with amyloid plaque buildup, and categorizes results as positive, intermediate or negative to help clinicians assess the likelihood of Alzheimer’s disease alongside clinical information and other findings. Roche said it is the first FDA-cleared single-biomarker blood test designed to support both rule-in and rule-out assessment of amyloid pathology across primary- and specialty-care settings. The clearance adds to a growing Alzheimer’s diagnostics market and follows earlier approvals for blood-based tests from Roche, Eli Lilly and other companies.