Roche secured CE marking for its Elecsys plasma phosphorylated-tau 217 blood test to rule in and rule out amyloid pathology. The test, developed with Eli Lilly, adds another non-invasive option for clinicians to diagnose Alzheimer’s-related amyloid status following FDA action on a comparable blood test from Fujirebio. Roche’s move extends the company’s push into end-to-end oncology and neurodiagnostics solutions using blood-based biomarkers. It also increases competition in the rapid adoption of plasma tests for dementia staging and patient selection. For biotech and diagnostic developers, CE clearance reinforces that regulatory pathways for blood biomarkers are increasingly established across markets, enabling faster clinical workflow integration.