Roche Receives CE Mark for New Blood Test to Detect Alzheimer's Pathology

Roche announced 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. 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. 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.”

“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, M.D., 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.”

Barriers to early and accurate diagnosis of Alzheimer’s disease exist worldwide. An estimated 75 per cent of people living with dementia remain undiagnosed and those who are diagnosed typically wait an average of around 3.5 years after cognitive decline symptoms are first noticed. With Alzheimer’s disease representing the most common cause of dementia, improving access to tests that detect Alzheimer ’s-related brain changes is critical to speeding up diagnosis. Current methods to confirm amyloid pathology, such as positron emission tomography (PET) scans and cerebrospinal fluid (CSF) assessments, can be difficult to access, expensive, and perceived as more invasive than a simple blood test. The pTau217 assay contributes to addressing the undiagnosed population, with reliable detection of AD pathology in individuals with early cognitive decline symptoms.

The Elecsys pTau217 CE Mark was granted based on data from retrospective studies of a real-world population at the earliest stages of Alzheimer’s (Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia), a point where individuals may notice memory changes but still live independently. This focus ensures the test performs where it is needed most: at the dawn of the disease, when timely intervention has the greatest potential to preserve independence and slow the progression of decline.