Pharma Focus Europe

Roche's Elecsys Amyloid Plasma Panel granted FDA Breakthrough Device Designation to enable a timely diagnosis of Alzheimer’s disease

Wednesday, July 20, 2022

Roche has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the Elecsys® Amyloid Plasma Panel, an innovative solution designed to enable early detection of Alzheimer's disease. The Elecsys Amyloid Plasma Panel test detects and measures biomarkers associated with Alzheimer's disease in blood plasma, providing an indication for further confirmatory testing. Roche is the first in-vitro diagnostics manufacturer to receive this designation for a blood-based biomarker test for Alzheimer's.

Alzheimer's disease is the most prevalent form of dementia, affecting over 55 million individuals worldwide, with more than 10 million new cases each year. However, there are significant barriers to early and accurate diagnosis, as up to 3 out of 4 people with symptoms of Alzheimer's disease remain undiagnosed, and those who receive a diagnosis often experience a delay of 2.8 years on average.

Thomas Schinecker, CEO of Roche Diagnostics, emphasized the importance of early diagnosis in improving the lives of individuals with Alzheimer's disease. The new diagnostics test has the potential to streamline the patient's journey, enabling faster and easier access to a confirmatory diagnosis. This, in turn, allows individuals with Alzheimer's disease and their caregivers more time to plan and prepare for the future.

Currently, the diagnosis of Alzheimer's disease primarily relies on clinical symptoms and cognitive assessments, often resulting in diagnoses at more advanced stages of the disease. The Elecsys Amyloid Plasma Panel will be the first qualitative test to combine the results of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma. Elevated levels of pTau occur in the early stages of Alzheimer's, while the presence of APOE E4 represents the most common genetic risk factor for the disease. Patients who test negative with the Elecsys Amyloid Plasma Panel are unlikely to have amyloid positivity and should be further investigated for alternative causes of cognitive decline.

The Elecsys Amyloid Plasma Panel holds the potential to improve the identification of patients who require additional confirmatory testing, such as PET scans or cerebrospinal fluid (CSF) testing. This can facilitate a more timely and accessible diagnosis. Combined with other diagnostic tools and Roche's efforts in developing potential new treatments, this represents a significant step toward enhancing care and outcomes for individuals with Alzheimer's disease.

Roche has also received Breakthrough Device Designation for the Elecsys® ß-Amyloid (1-42) CSF and Elecsys® Phospho-Tau (181P) CSF in vitro diagnostic immunoassays. These tests measure ß-Amyloid (1-42) and Phospho-Tau concentrations in cerebrospinal fluid (CSF) in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease or other causes of dementia.

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