US FDA approves world’s first blood test for Alzheimer’s, and what it means

When her mother began forgetting names and losing her way home, Maria Torres feared the worst, but had no easy path to answers. Now, a simple blood test could finally offer families like hers the clarity they’ve long needed.

The US Food and Drug Administration (FDA), in a landmark diagnosis for dementia, has approved the world’s first blood test designed to detect dementia disease in its early stages.

The Lumipulse Plasma Ratio test, developed by Fujirebio Diagnostics, offers a less invasive and more accessible alternative to traditional diagnostic methods.

Alzheimer's disease, a progressive neurological disorder, affects over 6 million people in the United States, with numbers expected to rise significantly in the coming decades. Early and accurate diagnosis is crucial for managing the disease and exploring treatment options.

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The Lumipulse test works by measuring specific proteins in the blood that are associated with the presence of amyloid plaques in the brain, a hallmark of Alzheimer's disease.

Previously, detecting these plaques required costly and invasive procedures like PET scans or spinal taps. With this new blood test, a simple blood draw can provide valuable diagnostic information.

Clinical studies have demonstrated the test's efficacy, with results showing high accuracy in identifying amyloid plaques. In a study involving 499 cognitively impaired individuals, the blood test's findings closely matched those obtained from PET scans and spinal fluid tests.

The FDA emphasized that the test should be used in conjunction with other clinical evaluations to determine the appropriate course of action.

FDA Commissioner Martin A. Makary said,

"Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined. Knowing that 10 percent of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double."

The approval of the Lumipulse test also has implications for treatment accessibility. Two FDA-approved drugs, Leqembi and Kisunla, have shown promise in slowing the progression of Alzheimer's by targeting amyloid plaques. However, their use requires confirmation of plaque presence, which the new blood test can facilitate more efficiently.

Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health, remarked, "Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for US patients earlier in the disease."

While the test represents a significant advancement, experts caution that it is not intended for individuals without symptoms and should be administered under medical supervision.