Swiss pharmaceutical giant Roche shared new late-breaking data for its Elecsys Amyloid Plasma Panel, which shows the test can rule out Alzheimer’s-related amyloid pathology with good accuracy.
The Elecsys Amyloid Plasma Panel is a minimally invasive blood test that detects both phosphorylated Tau (pTau) 181 protein and apolipoprotein E4 (APOE4) in plasma. The panel is being jointly developed by Roche and Eli Lilly.
Roche presented the data at the 17th Clinical Trials in Alzheimer’s Disease Congress (CTAD) in Madrid, Spain, being held from October 29 to November 1.
In the study, the Elecsys Amyloid Plasma Panel demonstrated 91 percent sensitivity and 69.8 percent specificity.
It also demonstrated an impressive high negative predictive value (NPV) of 96.2 percent, which means that a negative result from the test could be used to rule out Alzheimer’s disease. The score was based on a 23.4 percent prevalence of amyloid positivity as determined by positron emission tomography (PET) scans.
The test would allow for the identification of symptomatic individuals with a low likelihood of amyloid pathology, a key hallmark of the disease, in the early stages of the Alzheimer’s disease continuum.
It would help clinicians determine whether Alzheimer’s could be ruled out or whether further evaluation and testing are required to confirm a diagnosis in patients with cognitive symptoms.
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The latest data for the Elecsys Amyloid Plasma Panel came from a prospective, multicenter study involving 492 patients across the US and Europe 55 to 80 years of age with cognitive decline or memory impairment.
The test’s performance remained consistent, showing minimal impact from factors like patient age, sex, body mass index (BMI) or kidney function impairment. Roche’s pTau181 biomarker assay showed similarly strong results when used independently.
The study marked the first global, industry-led prospective diagnostic trial to assess the test’s clinical performance in a patient population closely resembling those who might benefit from it.
Roche explained that the study included a subset of patients from a broader trial with diverse, inclusive criteria to validate the test’s efficacy across varied geographies and ethnic backgrounds. The company said further applications of the test with this comprehensive patient cohort are being explored in ongoing studies.
Commenting on the study’s findings, Roche Diagnostics CEO Matt Sause said in a statement: “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.”
Related: Roche’s Early Alzheimer’s Blood Test Gets FDA Breakthrough Device Designation
The Elecsys Amyloid Plasma Panel received FDA Breakthrough Device designation in July 2023.
Roche is also developing the Elecsys pTau217 blood test for the early detection of Alzheimer’s. The test received FDA Breakthrough designation in April this year.
A positive result on the Elecsys pTau217 assay, which measures phosphorylated Tau217 in plasma as a marker of Alzheimer’s disease, suggests a high likelihood of amyloid presence, as verified by amyloid PET scans or cerebrospinal fluid (CSF) tests.
Like the Elecsys Amyloid Plasma Panel pTau181 protein and APOE4 panel test, a negative result indicates a low probability of amyloid pathology to rule out Alzheimer’s in patients with symptoms.
Roche also presented new data for the test in a poster presentation at the meeting. The data came from a head-to-head study evaluating the test against Fujirebio’s plasma assay for pTau217 developed for its Lumipulse system.
Results from the blinded study showed that both the Elecsys and Lumipulse assays had strong accuracy in distinguishing between amyloid-negative and amyloid-positive samples. Both assays had 90 percent sensitivity and specificity.
However, the Elecsys test yielded a narrower range of samples with indeterminate results. Both assays are currently restricted to research use only.
Roche Elecsys’s blood biomarker diagnostic portfolio also features a neurofilament light chain (NfL) test for multiple sclerosis, an interleukin 6 (IL-6) immunoassay for neonatal sepsis, the Elecsys HBeAg quant assay for diagnosing and monitoring hepatitis B and the Anti-HEV IgM and Elecsys Anti-HEV IgG immunoassays for detecting hepatitis E virus (HEV) infections.
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