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Roche Receives CE Mark For Elecsys Ptau217 Blood Test For Alzheimer’S Disease 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. Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single-assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer's disease diagnosis for millions of patients around the world. 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. Barriers to early and accurate diagnosis of Alzheimer’s disease exist worldwide. An estimated 75% 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) 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. A positive Elecsys pTau217 blood test result indicates a high likelihood of amyloid pathology, a hallmark of Alzheimer’s disease. This can guide primary care clinicians to make timely referrals and provide specialists with the actionable data needed to advance patient evaluation and management. A negative result indicates a low likelihood of amyloid pathology, meaning clinicians may be able to rule out Alzheimer’s disease and avoid further invasive CSF or PET investigations, helping to preserve specialist resources by shifting clinical focus to other potential causes of cognitive symptoms. An indeterminate result requires additional testing to establish a diagnosis. Elecsys pTau217 should be used in conjunction with other clinical information. 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. In diagnostics, Roche offers one of the broadest portfolios of biomarker assays, including the blood-based Elecsys pTau217, Elecsys pTau181 and Elecsys ApoE4 tests, in addition to CSF assays and digital solutions. These enable more effective and timely detection, diagnosis, and monitoring of the disease across the care pathway. The company also provides a wide range of research-use-only (RUO) assays that advance scientific understanding and support future innovation.

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