FDA Approves First Blood Test for Alzheimer's Detection: A Milestone in Diagnostics

The U.S. Food and Drug Administration (FDA) has granted clearance for a groundbreaking blood test designed to detect amyloid plaques in the brain, a key indicator of Alzheimer's disease. This innovative test, developed through collaborative research led by the Indiana University (IU) School of Medicine, marks a significant advancement in diagnostic capabilities for Alzheimer's, a condition affecting over 7 million Americans, with projections estimating nearly 13 million by 2050 (Alzheimer's Association, 2023).

The test received FDA clearance on May 16, 2025, allowing healthcare providers to offer it to patients aged 55 and older who exhibit symptoms associated with Alzheimer's disease. According to Dr. Jeffrey Dage, a senior research professor of neurology at IU School of Medicine and a key contributor to the research, the test boasts an accuracy rate exceeding 90% in diagnosing the disease through a simple blood draw.

Dr. Dage's research, which began nearly a decade ago, focuses on phosphorylated tau, a protein linked to Alzheimer's disease that circulates in the bloodstream. Collaborating with institutions such as Mayo Clinic and Lund University in Sweden, Dr. Dage's team published a series of pivotal studies from 2018 to 2020, establishing the reliability of the blood test in detecting Alzheimer's pathology, achieving 96% accuracy compared to traditional methods like positron emission tomography (PET) scans and cerebrospinal fluid tests (Dage et al., 2018-2020).

"This offers a less invasive, more accessible, and scalable method to identify Alzheimer's pathology early in the disease process," Dr. Dage stated. The test measures the levels of phosphorylated tau (pTau217) and beta-amyloid protein (Aβ1-42), both of which are critical for diagnosing the disease.

Historically, Alzheimer's diagnosis has relied on more invasive procedures, such as PET scans and lumbar punctures for cerebrospinal fluid analysis, which can be costly and less accessible for many patients. The introduction of this blood test aims to democratize access to diagnosis and could facilitate earlier interventions, improving patient outcomes significantly (Alzheimer's Association, 2023).

Bruce Lamb, PhD, an IU Distinguished Professor and the executive director of the Stark Neurosciences Research Institute, emphasized the importance of fluid biomarkers in Alzheimer's research. He noted, "Fluid biomarkers provide a bridge between basic and clinical research, enabling us to better understand Alzheimer's disease and develop effective treatments."

The need for new diagnostic tools is underscored by the increasing prevalence of Alzheimer's disease, which currently affects over 7 million people in the U.S. and is expected to rise sharply. With the advent of this blood test, medical professionals can offer earlier and more accurate diagnoses, which is vital for timely treatment and participation in clinical trials (Alzheimer's Association, 2023).

Dr. Dage's commitment to Alzheimer's research is personal, stemming from his experience as a caregiver for his mother, who passed away from dementia-related complications in 2019. He expressed gratitude for the patients and families involved in the research, stating, "While the test is a significant milestone, we must continue to refine it, expand its use, and ensure it reaches those who need it the most."

The IU School of Medicine's comprehensive Alzheimer's research program encompasses various initiatives, including basic and translational research, drug discovery, and clinical trials. As the blood test becomes integrated into routine healthcare practices, it promises to enhance understanding of Alzheimer's disease and improve diagnostic accuracy (IU School of Medicine, 2025).

In conclusion, the FDA's approval of this blood test represents a critical step forward in Alzheimer's diagnostics, providing hope to millions of families affected by this devastating disease. As research continues to evolve, the focus will remain on refining these technologies to ensure they are accessible and effective for all patients.

### Sources: 1. Alzheimer's Association. (2023). Alzheimer's Disease Facts and Figures. 2. Dage, J. et al. (2018-2020). Various studies on biomarkers for Alzheimer's Disease. 3. IU School of Medicine. (2025). News Release on FDA Approval of Alzheimer's Blood Test.