Blood-biomarker tests may aid in early diagnosis of Alzheimer's: Report

While early detection of Alzheimer’s disease is crucial for better outcomes, a report on Wednesday said that blood-based tests are emerging as valuable tools.

The report by GlobalData, a data and analytics company, offers accessible alternatives to PET scans and cerebrospinal fluid (CSF) analysis.

Currently, Alzheimer’s affects over 55 million people globally, and cases are projected to triple by 2050.

Advances in diagnostic methods that can make diagnosis faster, less invasive, and more affordable can help in the timely intervention of the neurodegenerative disease. However, the report said questions remain about their real-world impact on patient outcomes.

Ashley Clarke, Senior Medical Analyst at GlobalData said that blood-based biomarker tests that are cost-effective and efficient in early assessment, have taken a major leap forward in diagnostics with it being used for conditions like heart attacks.

“For Alzheimer’s disease, reliable and accessible testing could lead to earlier detection, giving patients more time to pursue interventions and lifestyle changes,” Clarke said.

According to GlobalData’s Pipeline Products Database, more than 150 in vitro diagnostic tests for Alzheimer’s disease are currently in development. However, the USFDA has yet to grant full approval to blood-based Alzheimer’s tests.

“With high negative predictive values, blood-based tests could serve as reliable screening tools, helping reserve hospital resources for procedures such as PET scans for patients most likely to need them,” Clarke said.

GlobalData reports that at least five pipeline devices are now in the regulatory approval process across the US and Europe, yet ethical and regulatory challenges persist.

These tests raise concerns about overdiagnosis, exposure of sensitive health data, and the potential for insurers to adjust premiums based on test outcomes.

Predictive testing also introduces ethical considerations around informed consent, and potential psychological impacts for patients learning their risks in a disease still lacking a cure, the report said.

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