New data presented by Roche at the at the 17th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, Spain highlight the potential of the Elecsys Amyloid Plasma Panel and Elecsys ptau181 for ruling out Alzheimer’s disease related amyloid pathology with very good accuracy.
In the largest worldwide clinical trial of its kind, the blood-based test showed very good accuracy in ruling out Alzheimer's pathology in those being investigated for the disease, potentially avoiding the need for further invasive and unnecessary tests.
In the prospective, multicentre study, which included 492 patients across the US and Europe, the Roche Elecsys Amyloid Plasma Panel was able to rule out Alzheimer’s disease with a high negative predictive value (NPV) of 96.2% based on a 23.4% prevalence of amyloid positivity according to positron emission tomography (PET) scans, with 91.0% sensitivity and 69.8% specificity. The performance of the test was only minimally impacted by the patients’ age, sex, body mass index or impaired kidney function. Roche’s pTau181 biomarker performed similarly as a standalone assay.
“The data from this large-scale study in cognitively impaired individuals suggests that a fast and simple blood test could reliably rule out amyloid pathology, offering much-needed reassurance to patients and their families,” commented Matt Sause, CEO of Roche Diagnostics. “Alzheimer’s disease is one of the most challenging health issues of our time, and its impact on society is growing as the world’s population ages. For many people, getting a clear and timely diagnosis remains challenging. This test could help patients to receive the right care at the earliest opportunity.”
The Elecsys Amyloid Plasma Panel, which received FDA Breakthrough Device Designation in July 2023, is a minimally invasive blood test that measures phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in plasma. This is the first industry trial of its kind (globally prospectively collected diagnostic registrational clinical trial) to investigate the test’s clinical performance in a patient population that reflects as closely as possible the patients who could benefit from the test. It involved a subset of patients from a wider trial looking at a highly diverse set of patients with broad inclusion criteria, to ensure the test could be used effectively across different geographies and ethnicities. Further potential uses for the test are being explored with the rich patient population.
In addition to data on the Elecsys Amyloid Plasma Panel and pTau181, Roche also presented data for its Elecsys pTau 217 assay which is currently in development and also received FDA Breakthrough Device Designation earlier this year. The results from this latest study demonstrate high accuracy of amyloid pathology detection in comparison with another available pTau 217 test.
The Elecsys Amyloid Plasma Panel measures phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human blood plasma. Elevations in pTau181 occur in the early stages of Alzheimer’s disease, while the presence of APOE4 constitutes the most common genetic risk factor for Alzheimer’s disease. The result is intended for consideration in conjunction with other clinical information to advise for further confirmatory testing with amyloid positron emission tomography (PET) or cerebrospinal fluid (CSF) testing. Patients testing negative with the Elecsys Amyloid Plasma Panel are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.
Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) (pTau217) in human plasma from individuals aged 60 years and older. The test is intended for use as an aid in identifying amyloid pathology, a pathological feature of Alzheimer’s disease.