The FDA has granted Breakthrough Device Designation to Roche's Elecsys pTau217 assay, a blood test developed in collaboration with Eli Lilly and Company, designed to identify the presence or absence of amyloid pathology in individuals aged 60 and older. This designation aims to expedite the development and review of the device, potentially leading to earlier and more accurate diagnoses of Alzheimer's disease (AD). The test could ensure that patients receive appropriate care, including participation in clinical trials and access to approved disease-modifying therapies.
Significance of Early Alzheimer's Diagnosis
Early and accurate diagnosis of Alzheimer's disease is crucial for effective management and potential mitigation of its impact. Matt Sause, CEO of Roche Diagnostics, emphasized the critical role of diagnostics in addressing the global health challenge posed by the rising incidence of dementia, noting that 75% of cases remain undiagnosed. The Elecsys pTau217 assay is poised to play a pivotal role in improving the lives of patients worldwide by facilitating timely intervention.
The Role of pTau217 as a Biomarker
pTau217, a phosphorylated fragment of the protein tau, serves as a biomarker to distinguish Alzheimer's disease from other neurodegenerative disorders. The Elecsys pTau217 assay is designed as an in vitro diagnostic immunoassay for the quantitative determination of pTau217 in human plasma. A positive result indicates a high likelihood of positive amyloid PET/CSF results, while a negative result suggests the opposite. An indeterminate result indicates uncertainty regarding amyloid PET/CSF results. The pTau217 result should be used in conjunction with other clinical information to aid in the diagnostic pathway.
Impact on Alzheimer's Care and Research
Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, highlighted the collaboration with Roche Diagnostics as a milestone in advancing the Alzheimer's diagnostic ecosystem. The development of the Elecsys pTau217 plasma assay is expected to meet the growing need for additional diagnostic tools, enabling timely and accurate diagnoses for individuals with Alzheimer's disease. According to an Alzheimer’s Association report, an estimated 6.7 million Americans aged 65 and older had Alzheimer dementia in 2023, and this number could grow to 13.8 million by 2060. In 2019, AD was listed as the sixth-leading cause of death in the United States with 121,499 deaths, underscoring the urgent need for improved diagnostic and therapeutic strategies.
Breakthrough Device Program
The FDA's Breakthrough Device Program is designed for medical devices that could provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. This program expedites the development and review of such devices, facilitating quicker access to innovative solutions for patients in need.
