Roche Receives CE Mark for Elecsys® Plasma Phosphorylated-Tau 217 Blood Test for Alzheimer’s Detection
Roche has announced the receipt of CE Mark approval for its Elecsys® plasma phosphorylated-tau 217 (pTau217) blood test, developed in collaboration with Eli Lilly. This test is designed to measure the pTau217 protein, indicating amyloid pathology associated with Alzheimer’s disease. The test aims to provide earlier and simpler diagnosis of Alzheimer’s, addressing the significant number of undiagnosed dementia cases and reducing the reliance on invasive diagnostic methods. It is intended to be used alongside other clinical information, facilitating timely treatment decisions for patients showing cognitive decline symptoms.
Basel, 12 May 2026 – Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received CE Mark for Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and Company and designed to measure the phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease.1,2,4,7,8 The same cutoffs (high and low) of the blood test can be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people presenting with symptoms or complaints of cognitive decline.1,2,4,5 The early detection of the amyloid pathology is critical for Alzheimer’s diagnosis and treatment, as it enables individuals, families, and caregivers to understand the cause of symptoms, access appropriate care, and actively contribute to the planning of next steps.3,4,5,9,10