Roche has received the CE mark for its Elecsys pTau217 blood test, 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 diagnostic was developed in collaboration with Eli Lilly and Company.
“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, with an estimated 75% of people living with dementia remaining undiagnosed. Those who are diagnosed typically wait an average of around three and a half 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) scan and cerebrospinal fluid (CSF) assessment — can be difficult to access, expensive, and can be 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.
The Elecsys pTau217 assay is clinically robust, supporting flexible workflows and sample handling aligned with routine processes. Data support its potential to refine diagnosis by providing a single, robust biomarker that is broadly available across Roche’s large installed base of instruments with a high-throughput, full-automation assay.
Following CE mark approval, this simple and convenient blood test will leverage Roche’s broad installed base of instruments across countries accepting the CE mark, positioning Elecsys pTau217 for rapid and wide implementation in routine practice.
This scale makes it easier for laboratories to bring accurate, minimally invasive Alzheimer’s testing closer to patients and clinicians throughout countries accepting CE mark, with the potential for expansion to the US, subject to FDA approval later this year.