Roche has received CE Mark approval for Elecsys® pTau217, a blood-based diagnostic test designed to detect phosphorylated Tau (pTau) 217 protein, a key biomarker associated with amyloid pathology and Alzheimer’s disease. Developed in collaboration with Eli Lilly and Company, the assay is the first blood test for Alzheimer’s pathology with a single-assay design capable of both ruling in and ruling out amyloid pathology across primary and secondary care settings.

The test is designed for individuals presenting with symptoms or complaints of cognitive decline and enables clinicians to use the same high and low cutoff values across different care environments. By offering a minimally invasive alternative through a standard blood draw, Elecsys® pTau217 aims to simplify and expand access to Alzheimer’s disease diagnostics while maintaining accuracy comparable to cerebrospinal fluid diagnostics when benchmarked against PET-CT imaging.

The announcement addresses one of the most pressing challenges in dementia care worldwide: delayed and missed diagnoses. Roche noted that an estimated 75% of people living with dementia remain undiagnosed, while those who are diagnosed often wait an average of 3.5 years after symptoms first appear. As Alzheimer’s disease remains the leading cause of dementia globally, improving access to reliable and scalable diagnostic tools is increasingly viewed as essential for earlier intervention and treatment planning.

“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 CE Mark was granted based on retrospective studies conducted in real-world patient populations at the earliest stages of Alzheimer’s disease, including individuals with Subjective Cognitive Decline, Mild Cognitive Impairment, and Mild Dementia. Roche stated that the focus on early-stage populations is intended to ensure the assay performs at the point where therapeutic intervention and care planning may have the greatest long-term impact.

Current confirmatory methods for amyloid pathology, including PET imaging and cerebrospinal fluid testing, remain limited by accessibility, cost, and invasiveness. Roche positions Elecsys® pTau217 as a scalable alternative that could support broader adoption of Alzheimer’s testing within routine clinical workflows, potentially expanding access to earlier diagnosis for millions of patients worldwide.