Roche's Blood Test for Early Alzheimer's Diagnosis Receives FDA Breakthrough Device Designation

Roche announced today that its Elecsys pTau217 assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA).

Developed in partnership with Eli Lilly and Company, blood test aims to identify amyloid pathology in individuals, aiding in their access to appropriate care, including clinical trials or approved therapies.

If approved, this test could significantly expedite access to accurate diagnoses, potentially alleviating the burden of Alzheimer’s disease on individuals and society.

The global incidence of dementia, with many cases remaining undiagnosed. Emphasized the pivotal role of diagnostics in addressing this challenge, expressing confidence in the significance of pTau217 in Alzheimer’s diagnosis. 

Roche plans to leverage its expansive network of diagnostic systems worldwide to ensure widespread access to this test.

Describing the Elecsys pTau217 plasma assay as a milestone in their collaboration with Roche, aimed at advancing Alzheimer’s diagnostics. Emphasized the growing need for additional diagnostic tools to facilitate timely and accurate diagnoses.

pTau217, a phosphorylated fragment of the tau protein, has demonstrated promising capabilities in distinguishing Alzheimer’s disease from other neurodegenerative disorders in research settings.

Roche and Lilly, as leaders in Alzheimer’s innovation, aspire to accelerate testing and diagnosis through this collaboration, aiming to address the significant unmet medical needs.




Harvard Medical School - Leadership in Medicine Southeast Asia47th IHF World Hospital CongressHealthcare CNO Summit - USAHealthcare CMO Summit - USA