Roche, a global pharmaceutical and diagnostics leader, announced that it has secured the CE Mark for its Elecsys® pTau181 test, a significant advancement in the diagnosis of Alzheimer’s disease. This minimally invasive, blood-based diagnostic tool is designed to measure phosphorylated Tau (pTau) 181 protein, a crucial biomarker indicative of amyloid pathology, which is a hallmark feature of Alzheimer’s. Notably, the Elecsys pTau181 is the first In Vitro Diagnostic Regulation (IVDR) certified test specifically approved to help rule out Alzheimer’s associated amyloid pathology.
Developed in collaboration with Eli Lilly and Company, the Elecsys pTau181 test offers clinicians a valuable tool, used in conjunction with other clinical information, to determine if Alzheimer’s disease is the underlying cause of a patient’s cognitive decline. A negative result from this blood test could spare patients from undergoing more invasive, costly, and often difficult-to-access confirmatory investigations, such as positron emission tomography (PET) scans or cerebrospinal fluid (CSF) assessments. This is particularly impactful given that up to 75% of individuals exhibiting Alzheimer’s symptoms remain undiagnosed, and those who do receive a diagnosis often face an average delay of nearly three years after symptom onset.
Matt Sause, CEO of Roche Diagnostics, highlighted the increasing burden of Alzheimer's disease on society due to the aging global population. He emphasized that the Elecsys pTau181 test can provide much-needed clarity for patients and caregivers by enabling an earlier and less invasive diagnostic pathway. This, in turn, has the potential to improve patient outcomes and alleviate the financial strain on healthcare systems worldwide. By facilitating the "rule-out" of Alzheimer's, patients can be directed to the appropriate care pathways more quickly, whether for Alzheimer's or other causes of cognitive impairment.
The CE Mark approval for the Elecsys pTau181 test is strongly supported by robust clinical data derived from a prospective, multicenter study. This study included 787 patients across the U.S., Europe, and Australia, reflecting a diverse patient population (aged 55-80 years) that closely mirrors those who would benefit from the test in real-world clinical practice. The results demonstrated the test's high reliability in ruling out Alzheimer’s disease, achieving a negative predictive value (NPV) of 93.8% based on a 22.5% prevalence of amyloid positivity as determined by PET scans, with a sensitivity of 83.6%. Furthermore, the test’s performance remained largely consistent regardless of patient age, gender, body mass index, or even impaired kidney function, underscoring its broad applicability across various care settings, including primary care where many patients first present with cognitive concerns.
For those with positive results from the Elecsys pTau181 blood test, it serves as an indicator to proceed with further confirmatory testing for Alzheimer's pathology. This earlier identification is crucial, as new Alzheimer's treatments are often most effective when initiated in the early stages of disease progression, empowering patients to make informed decisions about their future care and lifestyle.
Beyond the pTau181 test, Roche is actively developing the Elecsys pTau217 blood test, another in-vitro diagnostic immunoassay aimed at quantitatively determining Phospho-Tau (217P) protein in human plasma to aid in identifying amyloid pathology. Recent data on Elecsys pTau217 indicates its high accuracy in detecting amyloid pathology and superior stability compared to a pTau217/Aβ42 ratio in blood and plasma samples, even at room and refrigerator temperatures. Combined with its high-throughput and full automation capabilities, the Elecsys pTau217 has the potential to become a standalone, scalable test for widespread implementation in routine clinical practice globally.
Roche's commitment to addressing Alzheimer's disease spans over two decades of scientific research. The company's comprehensive Alzheimer’s portfolio encompasses both investigational medicines targeting various disease mechanisms and stages, such as trontinemab, and a range of diagnostic tools, including digital solutions, blood-based tests, and CSF assays. By integrating its strengths in diagnostics and pharmaceuticals with data insights from clinical practice, Roche aims to pioneer personalized healthcare solutions and transform how Alzheimer's disease is detected, diagnosed, and monitored, ultimately striving to preserve the cognitive health and quality of life for millions worldwide.