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Roche’s diagnostic test for Alzheimer’s receives FDA Breakthrough Device Designation

Alzheimer's affects more than 55 million people globally and is the most common form of dementia

Alzheimer's disease

Roche’s Elecsys Amyloid Plasma Panel has received a Breakthrough Device Designation from the US Food and Drug Administration (FDA) for use in the treatment of symptomatic patients being assessed 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 Alzheimer's disease biomarkers in blood plasma. These biomarkers can signal a need for further tests.

Roche is the first in-vitro diagnostics manufacturer to be given this designation for a blood-based 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 global difficulties in getting early and accurate diagnoses for Alzheimer's disease. Up to three out of four people who have symptoms of Alzheimer’s disease have not yet been diagnosed. Those who have been diagnosed have usually faced an average wait of 2.8 years for confirmation.

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

The diagnosis of Alzheimer's disease is typically based on clinical symptoms, including cognitive assessment, with a number of patients diagnosed when their disease has already advanced. The Elecsys Amyloid Plasma Panel will be the first qualitative test that combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma.

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

Roche’s test has the potential to allow for a better identification of patients that need further confirmatory testing. This is possible through a positron emission tomography (PET) scan or cerebrospinal fluid (CSF) testing, which can ensure a more timely and accessible diagnosis.

Article by
Fleur Jeffries

19th July 2022

From: Research, Regulatory

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