Roche Amyloid Plasma Panel for Alzheimer Disease Demonstrates Negative Predictive Value of 96%, Company Announced

A blood test currently in development by Roche that measures phosphorylated Tau (pTau) 181 protein and apolipoprotein (APOE) E4 in plasma ruled out Alzheimer disease with a negative predictive value (NPV) of 96.2%, according to a company news release.

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Data on the performance of the Elecsys amyloid plasma panel are from a prospective multicenter trial with 492 participants conducted across the US and Europe and were presented at the 17th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, Spain.

Study participants were between 55 and 80 years old and assessed with cognitive decline or memory impairment. The findings demonstrated that the amyloid plasma panel was 91% sensitive and 69.9% specific in identifying Alzheimer disease. The test’s high NPV was based on amyloid positivity prevalence of 23.4% according to results of positron emission tomography (PET) scan. The performance results, according to Roche, reflected only minimal impact of study participants’ demographics and metabolic health.

“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,” Matt Sause, CEO of Roche Diagnostics, said in the news release.

The global trial is the first of its kind, the company said, to investigate the Elecsys amyloid plasma panel in a highly diverse set of participants. Enrollment was based on broad inclusion criteria to ensure the test would perform effectively in a group of older adults that most closely reflects a real-world clinical population, spanning geography and ethnicities.

In July 2023, Roche received FDA Breakthrough Device Designation for the Elecsys panel that measures 2 proteins associated with the presence and progression of Alzheimer disease. Early stages of the disease are characterized by elevations in pTau181; detection of APOE4 indicates the presence of the most common genetic risk factor for AD, according to Roche. Findings from the combined assay are intended to augment other clinical data that may support additional investigations with amyloid PET or cerebrospinal fluid testing. Negative findings on the amyloid plasma panel are likely accurate, so individuals with symptoms of cognitive decline should undergo further workup for potential causes, the company advised.

Roche also presented data for its Elecsys pTau 217 assay at the 2024 CTAD meeting. The assay is currently in development and was also awarded 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, according to the news release.

Estimates are that up to 75% of individuals living with AD are symptomatic but undiagnosed. Those who do receive a diagnosis have waited nearly 3 years, on average, since their symptoms began before seeking help. The pace of the journey to diagnosis must be improved and access to appropriate resources made more equitable, Roche said.

“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.”

Source: Roche presents new data at CTAD, demonstrating its growing momentum in diagnostics for Alzheimer’s disease. News release. Roche. October 31, 2024. Accessed October 31, 2024. https://www.roche.com/investors/updates/inv-update-2024-10-31