Roche announced that its Elecsys pTau217 assay received Breakthrough Device Designation from the U.S. 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 biomarkers2. As global leaders in Alzheimer's innovation, Roche and Lilly hope that this collaboration can bring additional speed and scale to testing and diagnosis in this important area of unmet medical need.

Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau(217P) in human plasma from individuals aged 60 years and older. The test is intended for use as an aid in identifying amyloid pathology, a pathological feature of Alzheimer's disease. A positive Elecsys pTau 217 result indicates a high likelihood of having a positive amyloid PET/CSF result.

A negative Elecsys pTau216 result indicates a high likelihood of have a negative amyloid PET/CSF result. An indeterminate pTau217 result indicates uncertainty on the amyloid PET/CS F result. The pTau217 result should be used in the diagnostic pathway in conjunction with other clinical information.

With more than two decades of scientific research in Alzheimer's, Roche is working toward a day when can detect the disease early and stop its progression to preserve what makes people who they are. Today, the company's Alzheimer's portfolio spans investigational medicines for different targets, types and stages of the disease. This includes trontinemab, an innovative Brainshuttle anti-amyloid treatment that is specifically engineered to cross the blood-brain barrier.

On the diagnostics side, it also includes approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor the disease. Yet the global challenges of Alzheimer's go well beyond the capabilities of science, and making a meaningful impact requires collaboration both within the Alzheimer's community and outside of healthcare. The company will continue to work together to work together with the development of the disease.