FDA Grants Breakthrough Device Designation to Assay Supporting Earlier Diagnosis of Alzheimer Disease


If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.

The FDA has granted breakthrough device designation to Elecsys pTau217 assay (Roche; Eli Lilly and Company), a blood test being developed to help identify the presence or absence of amyloid pathology in individuals. The device is intended to help providers ensure they provide appropriate care, including participation in clinical trials or access to approved disease-modifying therapies, according to the press release.1

3d rendered medically accurate illustration of amyloid plaques on a alzheimer nerve cell | Image Credit: Sebastian Kaulitzki - stock.adobe.com

Image Credit: Sebastian Kaulitzki - stock.adobe.com

If approved, the test could provide more timely and accurate diagnosis, hopefully mitigating the impact of Alzheimer disease (AD) on individuals and the community.1

“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,” Matt Sause, CEO of Roche Diagnostics, said in a press release. “We believe pTau217 is going to be crucial in the diagnosis of [AD], a condition where Roche Diagnostics is committed to improving the lives of patients worldwide.”1

According to an Alzheimer’s Association report, an estimated 6.7 million Americans aged 65 and older had Alzheimer dementia in 2023. By 2060, the number could grow to 13.8 million. In 2019, AD was listed as the sixth-leading cause of death in the United States with 121,499 deaths, according to the report. Additionally, deaths from stroke, heart disease, and HIV decreased between 2000 and 2019, but from AD increased by more than 145%. Investigators of the report said that the trajectory of deaths due to AD was likely increased by the COVID-19 pandemic in 2020 and 2021.2

According to the press release, pTau217 is a phosphorylated fragment of the protein tau, used as a biomarker to distinguish AD from other neurodegenerative disorders. The Elecsys pTau217 assay is intended as an in vitro diagnostic immunoassay to determine the presence and quantity of pTau217 in human plasma of individuals aged 60 and older. A positive result indicated that there is a high likelihood of having positive amyloid PET/CSF results, and a negative assay indicated the opposite. An indeterminate result indicated uncertainty on the amyloid PET/CSF results, according to the press release.1

Key Takeaways

  1. The blood test aims to identify the presence of amyloid pathology, a hallmark of AD, potentially leading to earlier and more accurate diagnoses.
  2. A timely diagnosis can ensure patients receive appropriate care, including participation in clinical trials and access to future therapies.
  3. With the rising number of AD cases, this blood test has the potential to significantly impact patient lives and health care systems.

“The development of the Elecsys pTau217 plasma assay is another milestone in our collaboration with Roche Diagnostics that will advance the Alzheimer diagnostic ecosystem,” Anne White, executive vice president of Eli Lilly and Company and president of Lilly Neuroscience, said in the press release. “We’re excited to help meet the growing need for additional diagnostic tools to enable a timely and accurate diagnosis for people with [AD].”1

According to the press release, the breakthrough device program is a voluntary program for certain medical devices that could provide more effective treatment or diagnosis for life-threatening or irreversible disease or conditions, expediting the development and review of the devices by the FDA.1

1. Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis. News release. Roche. April 11, 2024. Accessed April 16, 2024. https://www.roche.com/media/releases/med-cor-2024-04-11
2. 2023 Alzheimer's disease facts and figures. Alzheimers Dement. 2023;19(4):1598-1695. doi:10.1002/alz.13016
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