Roche Alzheimer’s Blood Test Gains EU Approval
New Diagnostic Tool Offers Hope for Earlier Alzheimer’s Detection
European Union citizens now have expanded access to Roche’s Elecsys pTau181 blood test, a crucial diagnostic aid for identifying Alzheimer’s disease. This approval signifies a significant step forward in managing cognitive decline, offering a less invasive alternative to traditional diagnostic methods.
Breakthrough Blood Test for Alzheimer’s
The Elecsys pTau181 test, already approved in the United States since 2022, has received its CE Mark. This automated in-vitro diagnostic assay measures phosphorylated tau (p-Tau)181, a key indicator of amyloid pathology and a hallmark of Alzheimer’s disease. It functions as a powerful rule-out tool.
A negative result from this test reliably suggests the absence of amyloid pathology, potentially reducing the need for more invasive procedures like PET scans or lumbar punctures. This allows clinicians to better manage and triage patients experiencing cognitive decline at earlier stages.
“The burden of Alzheimer’s disease on society and healthcare systems is increasing as the world’s population ages. With Elecsys pTau181, doctors can give patients and their caregivers the clarity they need when establishing the cause of cognitive decline. By enabling an earlier and less invasive diagnosis, this test has the potential to improve patient outcomes and decrease costs for healthcare systems worldwide.”
—Matt Sause, Chief Executive Officer at Roche
Evidence-Based Validation
The European Union’s decision was informed by a prospective, multicenter study involving 787 participants across the US, Europe, and Australia. The study demonstrated the test’s efficacy in ruling out Alzheimer’s disease, achieving a high negative predictive value of 93.8%. The test’s performance was minimally affected by factors such as age, gender, body mass index, or impaired kidney function.
Impact on Alzheimer’s Treatment Landscape
The EU approval arrives at a critical juncture, coinciding with the advent of new anti-amyloid therapies. These treatments, including lecanemab (Leqembi) and donanemab (Kisunla), have shown greater effectiveness when administered in the disease’s initial phases. Early and accurate diagnosis, facilitated by tools like the Elecsys pTau181 test, is becoming increasingly vital for patient access to these disease-modifying treatments.
In 2023, the FDA also granted clearance for Roche’s Elecsys assays for beta-amyloid and total tau in cerebrospinal fluid. These, along with the pTau181 test, assist clinicians in gaining a comprehensive biological understanding of potential Alzheimer’s disease, supporting a more definitive diagnosis.
The increasing prevalence of Alzheimer’s, affecting an estimated 6.7 million Americans aged 65 and older, underscores the urgent need for accessible and reliable diagnostic tools. This blood test represents a significant advancement in meeting that demand (Alzheimer’s Association, 2024).
