Roche presents new data highlighting advances in Alzheimer’s diagnostics

Roche has announced new late-breaking data on its Elecsys Amyloid Plasma Panel (combination of pTau181 and ApoE4), for Alzheimer’s disease, at the 17th Clinical Trials in Alzheimer’s Disease congress (CTAD) in Madrid, Spain. Results show that the test, currently in development, could accurately rule out amyloid pathology – a hallmark of Alzheimer’s disease – in a broad population with varying cognitive impairment, as seen in routine clinical practice¹.

This could allow clinicians to rule out Alzheimer’s disease as a possible cause of cognitive symptoms with a simple blood test, offering certainty and reassurance, potentially avoiding the need for further invasive and unnecessary tests.

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.

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.

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.

Roche is developing and delivering other solutions to more effectively detect, diagnose, and monitor Alzheimer’s disease and progressing research into investigational medicines for different targets, types, and stages of the disease. This includes trontinemab, a novel Brainshuttle^™ Aβ antibody that is currently in development and is specifically engineered for enhanced access to the brain to enable rapid reduction of amyloid in people with Alzheimer’s disease.

References

^[1] Kirste I., et al, Revamping Alzheimer's Disease Diagnostics: Evaluating Future IVD Plasma p-Tau 181 and ApoE4 Immunoassays for Amyloid Detection in a Multi-Center Study Reflective of Routine Clinical Practice, presented at CTAD, October 2024.

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