Roche’s diagnostic test for Alzheimer’s disease receives FDA Breakthrough Device designation


Roche’s Elecsys Amyloid Plasma Panel has received Breakthrough Device Designation from the U.S. Food and Drug Administration (FDA) for use in the treatment of symptomatic patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The plasma panel is a new test designed to detect Alzheimer’s disease earlier. It works by detecting and measuring biomarkers of Alzheimer’s disease in blood plasma. These biomarkers may signal a need for further testing.

Roche is the first in vitro diagnostics manufacturer to receive this designation for a blood biomarker test for Alzheimer’s disease.

Dementia affects more than 55 million people worldwide, with more than 10 million new cases each year. The most common form of dementia is Alzheimer’s disease.

There are worldwide challenges in obtaining early and accurate diagnoses of Alzheimer’s disease. Up to three out of four people with symptoms of Alzheimer’s disease have not yet been diagnosed. Those who were diagnosed typically had to wait an average of 2.8 years for confirmation.

Thomas Schinecker, CEO of Roche Diagnostics, said: “Our new diagnostic test has the potential to streamline a patient’s journey, improve speed and access to a confirmatory diagnosis, giving people with Alzheimer’s disease and their caregivers more time to plan and prepare for the future. ”

Diagnosis of Alzheimer’s disease is usually based on clinical symptoms, including cognitive assessment, with a number of patients diagnosed when their disease is already advanced. The Elecsys Amyloid Plasma panel will be the first qualitative test to combine the result of the phosphorylated protein Tau (pTau) 181 assay and the apolipoprotein (APOE) E4 assay in human plasma.

Elevations in pTau occur in the early stages of Alzheimer’s disease, while the presence of APOE E4 is the most common genetic risk factor for the disease. Patients with a negative Elecsys Amyloid Plasma Panel test are unlikely to be amyloid positive and should be investigated for other causes of cognitive decline.

Roche’s test has the potential to allow better identification of patients who need further confirmatory testing. This is possible with a positron emission tomography (PET) or a cerebrospinal fluid (CSF) test, which can guarantee a faster and more accessible diagnosis.


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