Roche Receives FDA Breakthrough Device Designation for Innovative Alzheimer’s Blood Test

Roche, in collaboration with Eli Lilly and Company, has achieved a significant milestone in the fight against Alzheimer’s disease. The U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to Roche’s Elecsys pTau217 plasma biomarker test. This designation accelerates the development and review of the assay, which is designed to identify amyloid pathology, a hallmark of Alzheimer’s disease. pTau217, a phosphorylated fragment of the tau protein, has demonstrated strong capabilities in research environments for differentiating Alzheimer’s disease from other neurodegenerative conditions, showing superior performance compared to other biomarkers.

The Elecsys pTau217 assay aims to transform the diagnostic landscape for Alzheimer’s by providing a simpler, more accessible method to detect the disease early. Elecsys Phospho-Tau (217P) is designed as an in-vitro diagnostic immunoassay to quantitatively measure the protein Phospho-Tau (217P) (pTau217) in the plasma of individuals aged 60 and above. It serves as a tool to help detect amyloid pathology, a key indicator of Alzheimer’s disease.

A positive result from the Elecsys pTau217 test suggests a high probability of a positive result in amyloid PET/cerebrospinal fluid (CSF) tests.

Conversely, a negative result from the Elecsys pTau217 test points to a high probability of a negative amyloid PET/CSF test result.

An indeterminate result from the pTau217 test reflects uncertainty regarding the amyloid PET/CSF outcome.

The outcome of the pTau217 test should always be considered alongside other clinical data in the diagnostic process.

Early and accurate diagnosis is crucial, as it can lead individuals to receive appropriate care quicker, including participation in clinical trials or therapies that could slow the disease’s progression.

The incidence of dementia is growing worldwide, with 75% of cases still remaining largely undiagnosed. There is a critical role for diagnostics to play in addressing this global health challenge. With the largest installed base of diagnostic systems globally, Roche is uniquely positioned to ensure broad access to this test.

Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, commented on the collaboration, “The development of the Elecsys pTau217 plasma assay is another milestone in our collaboration with Roche Diagnostics that will advance the Alzheimer’s diagnostic ecosystem.”

This breakthrough is part of Roche’s broader commitment to Alzheimer’s research, which spans more than two decades and includes both innovative medicines and diagnostic tools. The company’s efforts extend to a diverse portfolio aimed at various targets, types, and stages of the disease, striving for a future where Alzheimer’s can be detected early and its progression halted.

Reference: https://diagnostics.roche.com/us/en/news-listing/2024/roche-granted-fda-breakthrough-device-designation-ptau217-blood-test-support-earlier-alzheimers-disease-diagnosis.html

Check Also

USA CDC on COVID-19 Vaccine-Related Deaths

Recent revelations from The Epoch Times shed light on a controversial issue surrounding COVID-19 vaccines …

Sahifa Theme License is not validated, Go to the theme options page to validate the license, You need a single license for each domain name.