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Roche Receives FDA Breakthrough Device Designation for Blood Test Aimed at Earlier Detection of Alzheimer's Disease

Thursday, April 11, 2024

Roche (SIX: RO, ROG; OTCQX: RHHBY) has announced today that its Elecsys pTau217 assay has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA). Developed in collaboration with Eli Lilly and Company, this blood test aims to identify the presence or absence of amyloid pathology in individuals, assisting in ensuring they receive appropriate care. This may involve participation in clinical trials or access to approved disease-modifying therapies. If granted approval, the test could significantly enhance access to timely and accurate diagnosis, potentially alleviating the impact of Alzheimer’s disease on individuals and society.

Matt Sause, CEO of Roche Diagnostics, emphasized the urgent need for diagnostics to address the increasing incidence of dementia, with a significant portion of cases going undiagnosed. He stated, “We believe pTau217 is going to be crucial in the diagnosis of Alzheimer’s disease, a condition where Roche Diagnostics is committed to improving the lives of patients worldwide.”

Anne White, executive vice president of Eli Lilly and Company, and president of Lilly Neuroscience, expressed excitement about advancing the Alzheimer’s diagnostic ecosystem through this collaboration with Roche Diagnostics.

PTau217, a phosphorylated fragment of the protein tau, has demonstrated promising ability in research settings to differentiate Alzheimer’s disease from other neurodegenerative disorders, outperforming other biomarkers.

Roche and Lilly, as global leaders in Alzheimer’s innovation, aim to expedite testing and diagnosis in this critical area of unmet medical need through their collaboration.

The Elecsys pTau217 assay is intended for individuals aged 60 years and older to aid in identifying amyloid pathology, a key feature of Alzheimer’s disease. A positive result indicates a high likelihood of positive amyloid PET/CSF result, while a negative result suggests a high likelihood of negative amyloid PET/CSF result. An indeterminate result indicates uncertainty on the amyloid PET/CSF result. It should be used in conjunction with other clinical information in the diagnostic pathway.

Roche's Alzheimer’s portfolio includes investigational medicines targeting different aspects and stages of the disease, along with approved and investigational diagnostic tools, aiming to enhance detection, diagnosis, and monitoring of the disease.

The Breakthrough Devices Program, under which Elecsys pTau217 received designation, expedites the development and review of medical devices providing more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.



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