FDA Approves First Blood Test to Aid in the Diagnosis of Alzheimer’s Disease

About Tori Thurmond

Tori Thurmond combines her creative writing background with her marketing experience in her role as the Content Specialist at Brookdale. When she's not writing, she's probably spending time with her two cats or knitting.

In May, the FDA cleared the first blood test for use in diagnosing Alzheimer’s disease for individuals 55 years and older. The Alzheimer’s Association states, “There are a variety of laboratory-developed tests on the market that can be used to detect blood-based biomarkers associated with Alzheimer’s. This is the first that has been cleared by the FDA for use.”

The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio test helps detect the presence of amyloid plaques in the brain, a classic sign of Alzheimer’s disease. While these plaques can be detected using amyloid PET brain scans before a person starts exhibiting clinical symptoms, PET scans can be costly and time-consuming. They also expose patients to radiation. The new Lumipulse test only requires a simple blood draw, allowing for a more accessible and less invasive way to detect early signs of Alzheimer’s disease.

According to the 2025 Alzheimer’s disease Facts and Figures special report, 4 in 5 Americans would want to know if they had the disease before it impacted their lives. “This test is very exciting, particularly for earlier diagnosis,” says Jill Ladaa, Brookdale’s Alzheimer’s and Dementia Gerontologist. “It’s a significant step forward, as it opens the door for earlier treatment and interventions, ultimately helping people live well with the disease and improving their quality of life.”

While this research is groundbreaking, it’s important to keep in mind that the results of the Lumipulse test are only one diagnostic tool in the fight against Alzheimer’s. The FDA notes that the test is intended for use in patients who are already showing signs of cognitive decline. The main risk associated with the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is the possibility of false positive or false negative test results. False negatives could delay appropriate care, while false positive test results could lead to unnecessary treatment and psychological distress.

“Research and advancements in Alzheimer’s disease have made significant progress over the past decade from diagnosis to treatment and intervention,” Ladaa states. “I remain hopeful that we will one day find a cure. Until then, we are committed to championing the needs of individuals living with Alzheimer’s disease and their families, so they can continue to live well with dignity and support.”

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