Roche granted FDA Breakthrough Device Designation for blood test to support earlier Alzheimer's disease diagnosis - Seite 2

About Elecsys pTau217
Elecsys Phospho-Tau (217P) is intended to be an in-vitro diagnostic immunoassay for the quantitative determination of the protein Phospho-Tau (217P) (pTau217) 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 pTau217 result indicates a high likelihood of having a positive amyloid PET/CSF result.

A negative Elecsys pTau217 result indicates a high likelihood of having a negative amyloid PET/ CSF result.

An indeterminate pTau217 result indicates uncertainty on the amyloid PET/CSF result.

The pTau217 result should be used in the diagnostic pathway in conjunction with other clinical information.

About Roche in Alzheimer’s disease
With more than two decades of scientific research in Alzheimer’s, Roche is working toward a day when we 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. We will continue to work together with numerous partners with the hope we can transform millions of lives.

About Breakthrough Device Designation
The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of a life-threatening or irreversibly debilitating disease or condition. This program is designed to expedite the development and review of these medical devices.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.