Roche Lands Breakthrough Designation for Alzheimer’s Test

Roche said that its Elecsys pTau217 assay has won Breakthrough Device Designation.

The blood test is being developed in collaboration with Eli Lilly and Company and will be used to help identify the presence or absence of amyloid pathology in individuals, which can help ensure they are able to receive appropriate care.

This may include participation in clinical trials or access to approved disease-modifying therapies.

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.

“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 Company, 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.