Roche and Eli Lilly’s FDA clearance for the Elecsys pTau217 Plasma test adds momentum to blood-based Alzheimer’s workflows, offering a rule-in/rule-out framework for amyloid pathology using a single biomarker. Lab operators including Labcorp and Quest plan to offer the test, increasing the reach beyond specialized PET or CSF centers. The broader market context continues to develop with multiple pTau- and amyloid-ratio tests already cleared or launching, and with regulators pushing consistent clinical cutoffs to reduce variability across settings. Together, these steps are shifting Alzheimer’s diagnosis toward scalable blood-based methods—while setting up continued competition on assay standardization, instrument compatibility, and real-world implementation speed.