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Roche's Blood Test for Alzheimer's Earns FDA Breakthrough Device Designation

Roche has announced that the US Food and Drug Administration (FDA) has awarded Breakthrough Device Designation to its Elecsys pTau217 blood test for the diagnosis of Alzheimer’s disease. This designation highlights the test's potential to revolutionize Alzheimer's diagnostics by swiftly identifying amyloid pathology, a key marker for early disease detection and personalized treatments.

The Elecsys pTau217 plasma biomarker test, developed in collaboration between Roche and Eli Lilly, could transform Alzheimer's diagnostics by identifying the presence or absence of amyloid pathology. This crucial information promises to streamline early diagnosis, offering patients access to timely and tailored care, including enrollment in clinical trials and approved disease-modifying therapies.

Matt Sause, CEO of Roche Diagnostics, emphasized the urgency of improved diagnostics in tackling the escalating global burden of dementia, stating, “The incidence of dementia is growing worldwide, with 75 percent of cases remaining undiagnosed. Consequently, there is a critical role for Diagnostics to play in addressing this global health challenge. We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease.”

The pTau217 biomarker, a phosphorylated fragment of the protein tau, has shown immense promise in distinguishing Alzheimer's disease from other neurodegenerative disorders. Its robust performance in research settings bodes well for its clinical utility compared to other biomarkers.

Anne White, Executive Vice President of Eli Lilly, stressing the collaborative effort's significance in advancing Alzheimer’s diagnostic capabilities. “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. 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.” White stated.

Pending regulatory approval, the Elecsys pTau217 plasma biomarker test holds the potential to redefine the landscape of Alzheimer’s diagnostics, heralding a new era of early intervention and personalized therapies.

About Elecsys pTau217

The Elecsys Phospho-Tau (217P) test is an in-vitro diagnostic immunoassay designed to measure Phospho-Tau (pTau217) in human plasma, specifically for individuals aged 60 and above. It aids in detecting amyloid pathology. A positive result suggests likely amyloid presence, a negative one suggests its absence, and an indeterminate result reflects uncertainty. The pTau217 results should be interpreted alongside other clinical information to guide the diagnostic process for Alzheimer’s disease.


About Author: Tracy Mokwe

With over 3 years of experience as a medical laboratory scientist and writer, I am passionate about translating complex scientific information into clear and accessible content. My expertise lies in medical sciences, laboratory science and research, digital health, AI, and cybersecurity in healthcare.

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