Roche has secured CE Mark approval for Elecsys pTau217, a blood-based test developed with Eli Lilly and Company aimed at detecting phosphorylated Tau (pTau) 217 — a key biomarker linked to amyloid pathology and Alzheimer’s disease.
The test is designed to help clinicians either rule in or rule out amyloid pathology in patients showing signs of cognitive decline, using the same cutoffs across both primary and specialist care. By identifying Alzheimer’s-related brain changes earlier, the assay could help accelerate diagnosis, guide care decisions sooner, and support families in planning for the future.
“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.”
“For millions of families navigating the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward meaningful care,” said Carole Ho, Executive Vice President and President, Lilly Neuroscience.
“Lilly’s collaboration with Roche on the Elecsys pTau217 assay was driven by a shared commitment to bringing this innovation into routine practice, overcoming complexity in testing and enabling patients to make informed decisions about the future.”
The approval comes against a backdrop of major global diagnostic gaps. Around 75% of people living with dementia remain undiagnosed, and those who do receive a diagnosis often wait an average of 3.5 years after symptoms first appear.
Current confirmation methods — including PET scans and cerebrospinal fluid testing — are costly, less accessible, and more invasive than blood-based alternatives.
Roche says the Elecsys pTau217 assay could help close that gap by enabling earlier, simpler detection of Alzheimer’s pathology in patients at the earliest stages of cognitive decline, including subjective cognitive decline, mild cognitive impairment, and mild dementia.
The company emphasizes that this is the point where intervention may have the greatest potential to preserve independence and slow disease progression.
