pTau217 Blood Test Regulatory and Coverage Progress

Multiple pTau217 assays advancing toward clinical use: Australia TGA approved Roche test, Quanterix targeting Q4 FDA decision for LucentAD Complete (10% indeterminate rate), ASAP Act pushing Medicare coverage. Real-world data shows pTau217 drops with lecanemab. Key barrier remains Medicare non-coverage for FDA-cleared tests. New blood biomarker proteomic modules add systems-level depth.