FDA Breakthrough Device Designation for Roche’s Alzheimer's blood test

Roche’s Elecsys pTau217 assay blood test, which is being developed in collaboration with Eli Lilly, has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). The test aids in identifying amyloid pathology, a key feature of Alzheimer’s disease, and the two firms believe the test could play an important role in improving access to early and accurate Alzheimer’s diagnosis.

If approved, the test could help rapidly broaden access to a more timely and accurate diagnosis and potentially mitigate the impact of Alzheimer’s disease on people and society. Identifying the presence or absence of amyloid pathology in individuals can help ensure they are able to receive appropriate care. This may include participation in clinical trials or access to approved disease-modifying therapies.

“The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed. Consequently, there is a critical role for diagnostics to play in addressing this global health challenge,” said Matt Sause, CEO of Roche Diagnostics. “We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide. We plan to leverage our installed base of diagnostic systems, which is the largest in the world, to ensure we are able to create access to this test for those who need it the most.”

“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,” said Anne White, Executive Vice President of Eli Lilly, and President of Lilly Neuroscience. “We’re excited to help meet the growing need for additional diagnostic tools to enable a timely and accurate diagnosis for people with Alzheimer’s disease.”

pTau217, which is a phosphorylated fragment of the protein tau, is a biomarker that has shown the ability in research settings to distinguish Alzheimer’s disease from other neurodegenerative disorders and has shown strong performance relative to other biomarkers.

Elecsys Phospho-Tau (217P) is intended to be an in vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) (pTau217) in human plasma from individuals aged 60 years and older. The test is intended for use as an aid in identifying amyloid pathology, a pathological feature of Alzheimer’s disease.


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