Expanding biomarker validation for Alzheimer’s disease diagnosis worldwide

The traditional method of detecting Alzheimer’s disease (AD) by relying on the brain’s amyloid plaques has limitations in accuracy and early detection. Although the industry has evolved significantly, these methods still require complex sample processing, repetitive collection and provide limited accessibility, especially in remote or resource-limited settings.

New research conducted in this field now focuses on measuring blood-based biomarkers to help improve early detection of AD and improve access by enabling faster, fewer invasive diagnostic options. Although blood markers such as P-TAU217, P-TAU181, Aβ42/40 ratio and NFL are increasingly validated in the United States and Europe, verification is still lagging behind in other parts of the world, such as Latin America and Australia. Fortunately, new research published in nature represents an important step forward.

Reduce inadequate diagnosis of global advertising

AD, especially at the earlier stages when treatment is most effective, is significantly underestimated in Latin American countries such as Brazil. By the time most patients are diagnosed, they have missed a critical window for early intervention and may no longer be eligible for promising clinical trials or treatments. Although blood-based AD biomarker tests are still primarily used for research purposes, they are slowly transitioning to limited clinical uses to support diagnostic decisions in the United States and Europe.

Although clinical use of blood markers remains limited in other parts of the world, the new study represents a critical step in incorporating biomarker testing into clinical practice in Brazil and other Latin American countries. This study has led to local implementation of two blood-based biomarker test suites that have great potential to reduce underdiagnostic inadequate advertising in Brazil and offer cheaper options than current alternatives.

In other parts of the world, such as Australia, New South Wales Health Pathology is the country’s largest public pathology service and is at the forefront of expanding blood-based biomarker testing, with more than 100,000 tests per day to support clinical and scientific research. Proving the clinical utility and cost-effectiveness of innovative blood biomarker testing can help pave the way for timely diagnosis and proactive care norms.

An important step towards expanding biomarker verification

AD results tend to be poor in low- and middle-income countries due to various factors, including diagnostic tools such as PET imaging or CSF analysis. The researchers found that by measuring P-TAU217 alone using innovative blood tests or combining ratios with Aβ42/40, the researchers were able to identify AD pathology in 145 elderly Brazilians with nearly 95% diagnostic accuracy in predicting disease progression.

This study highlights how methods of implementing blood-based biomarker testing lead to improved prognosis in patients, as blood tests can enable early detection, expanding treatments for patients who are eligible only at an earlier stage of disease progression. Especially in environments where traditional diagnostic methods are limited, blood-based biomarker testing provides a more cost-effective and easy-to-use option, and is faster invasive when providing results, especially in underresourced areas. As ongoing research continues to validate the accuracy of blood-based biomarker testing, the industry is getting closer to incorporating blood biomarker testing into routine screening in clinical settings.

Accelerate the opportunity to adopt blood biomarkers in advance

Research continues to help support the clinical utility of blood-based testing, including the use of dry point tests and multiple tests that can measure multiple biomarkers simultaneously. In addition, emerging findings provide new guidance for how clinicians interpret and act on outcomes. Although many blood-based tests are still only used for research purposes, leaders in the field are already investigating how dry plaque analysis can change patient testing, the next breakthrough in clinical treatment.

Furthermore, multiplexing testing has great promise in simplifying the clinical decision-making process by providing less sample and reducing more data for manual workflow steps. Although the incidence of Alzheimer’s disease has been at an all-time high global level, we are still embracing innovative blood biomarker testing in the clinical setting and ushering in the next wave of therapeutic breakthroughs for the disease.

Photo: Andre, Getty Images

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