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July 20, 2022

Roche obtains FDA breakthrough device designation for Alzheimer’s test

The test can be used in combination with other clinical information in symptomatic patients.

Roche has received breakthrough device designation from the US Food and Drug Administration (FDA) for its Elecsys Amyloid Plasma Panel for early detection of Alzheimer’s disease.

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The new minimally invasive test has been designed to detect and measure biomarkers of Alzheimer’s disease from a blood sample.

These biomarkers can help indicate the need for further confirmatory tests for the disease.

The company is claimed to be the first in-vitro diagnostics maker to earn this designation for a blood-based biomarker test to detect Alzheimer’s.

It noted that the Alzheimer’s disease diagnosis is typically based on clinical symptoms, including cognitive assessment, with many patients diagnosed when their disease has already advanced.

The Elecsys Amyloid Plasma Panel has been developed to be used in combination with other clinical information in symptomatic patients as well as other causes of cognitive decline.

It combines the result of the phosphorylated Tau (pTau) 181 protein assay and apolipoprotein (APOE) E4 assay in human plasma.

pTau elevations happen in the early stages of Alzheimer’s disease, while APOE E4 presence is the most common genetic risk factor for the disease.

The blood-based biomarker test has the potential to ensure better detection of patients in need of further confirmatory testing, which can be done either with a PET scan or cerebrospinal fluid (CSF) testing.

Roche Diagnostics CEO Thomas Schinecker said: “The key to transforming the life of people with Alzheimer’s disease is to diagnose as early as possible and intervene with the right care plans.

“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.”

Recently, the company introduced Elecsys HCV Duo immunoassay, a new dual antigen and antibody diagnostic test, for the hepatitis C virus.

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Medical Device Industry Landscape In Asia-Pacific

GlobalData's APAC Medical Devices Industry Landscape – 2022 free study breaks down the APAC medical devices market by segment and region and includes insights on local and global competitors, pipeline product developments, clinical trials studies, and significant deals in the industry. The APAC medical device industry witnessed significant developments, launches, implementations, and adoption of new medical device technologies in the past decade, however the high cost of devices, regulatory hurdles, reimbursement pressure, and healthcare budget constraints have challenged market expansion across various territories and segments. APAC is the fastest growing regional market for medical device clinical trials, with China and Japan emerging as major clinical trial hotspots. The growth in medical device clinical trials in the APAC region is attributed to an increase in research partnerships between biopharma companies and clinical research organizations (CROs). This report also provides an in-depth analysis of the medical device market's opportunities and challenges, the influence of COVID-19 on the market, and government activities aimed to develop the APAC medical device market.
by GlobalData
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