Product News: Roche granted FDA Breakthrough Device Designation for pTau217 blood test

Supporting earlier Alzheimer's disease diagnosis

12 Apr 2024

Roche has announced that its Elecsys pTau217 assay has received Breakthrough Device Designation from the US Food and Drug Administration (FDA). This blood test, which is being developed in collaboration with Eli Lilly and Company, 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.

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 biomarkers1.

"The incidence of dementia is growing worldwide, with 75% of cases remaining undiagnosed2. 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.”

“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.


  1. Janelidze et al. Nat Med. 2020;26(3):379386; Karikari et al. Lancet Neurol. 2020;19(5):422–433; Palmqvist et al. JAMA. 2020;324(8):772–781; Thijssen et al. Lancet Neurol. 2021;20(9):739–752; Mattsson-Carlgren et al. JAMA Neurol. 2023;80(4):360–369.
  2. Alzheimer’s Disease International. Internet; cited March 24, 2024.

Want the latest science news straight to your inbox? Become a SelectScience member for free today>>