CE mark granted for Elecsys pTau217 blood test for Alzheimer’s pathology detection – Roche
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.
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.
