Using Biomarker Testing to Advance Alzheimer Diagnostics: Margherita Carboni, PhD

WATCH TIME: 5 minutes

"Roche is committed to delivering Alzheimer diagnostics that truly reflect real-world patient diversity, ensuring that those tests are reliable and inclusive."

Blood-based assays provide a non-invasive and cost-effective method for detecting Alzheimer disease (AD) pathology, including amyloid deposits. In previous studies, plasma phosphorylated tau 217 (p-tau217) has shown high clinical utility as a biomarker for identifying amyloid pathology. The Elecsys Phospho-Tau 217 plasma prototype immunoassay (Roche Diagnostics International Ltd), granted breakthrough device designation by FDA, enables detection of amyloid pathology by quantifying plasma pTau217 levels. Currently, the Lumipulse G pTau217 plasma assay (Fujirebio) is available for research use only.

In a new head-to-head comparison study using a subset of data from the CREAD2 study (NCT03114657), findings showed that the Elecsys pTau217 assay detected amyloid pathology with high accuracy and highly correlated with the Lumipulse pTau217 assay. These results suggest that both fully automated Elecsys and Lumipulse pTau217 assays may hold clinical potential for detecting amyloid pathology; however, these assays need full validation and regulatory approval prior to clinical use. These findings were presented by coauthor Margherita Carboni, PhD, indication lead of neurology at Roche Diagnostics International, and colleagues, at the 2024 Clinical Trials on Alzheimer’s Disease (CTAD) conference, held October 29 to November 1, in Madrid, Spain.

Carboni sat down with NeurologyLive^® at the conference to discuss more about the study as well as the roundtable presented at the meeting surrounding the use of plasma p-tau217 assays in clinical practice for diagnosing AD. She spoke about how the p-tau217 biomarker helps to improve the accuracy of Alzheimer diagnostics compared with traditional methods. She also talked about the steps that the company has taken to ensure these biomarker tests are validated across diverse patient populations. Furthermore, Carboni explained the challenges that exist in translating biomarker data into practical diagnostics, and how Roche is aiming to address these.

Click here for more coverage of CTAD 2024.

REFERENCES
1. Perneczky R, et al. Head-to-Head Comparison of the Fully Automated Elecsys pTau217 Plasma Assay and the Lumipulse pTau217 Plasma Assay. Presented at: 2024 CTAD; October 29-November 1; Madrid, Spain. Poster LP069.