Roche receives CE Mark for Elecsys pTau217

Roche (RHHBY) announced that it has received CE Mark for Elecsys pTau217, a blood test developed in collaboration with Eli Lilly and Company (LLY) and designed to measure the phosphorylated Tau, or pTau, 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease. The same cutoffs 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. 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. “The launch of pTau217 marks a significant step in providing a simple, blood-based tool to diagnose Alzheimer’s much earlier in the patient journey,” said Matt Sause, CEO of Roche Diagnostics. “Today, many people face a long and difficult path to a diagnosis, often relying on specialised care and costly procedures. By bringing this advanced test into routine care, we are helping physicians to support patients and families with an earlier assessment that is critical for timely intervention, while reducing pressure on healthcare systems.”