EU Approves Groundbreaking Blood Test for Early Alzheimer’s Detection

Web Editor

May 16, 2025

a man is looking at a wall with a lot of skulls on it and a clock in the background, Évariste Vital

Developed by Japanese Multinational Fujirebio Diagnostics

The European Union has recently approved a novel blood test for early detection of Alzheimer’s disease, potentially enabling patients to start treatment sooner with newly approved medications that slow the progression of this debilitating neurological disorder.

The Test and Its Developer

This test, developed by the Japanese multinational Fujirebio Diagnostics, measures the proportion of two proteins in the blood. This ratio correlates with amyloid plaques in the brain, a distinctive marker of Alzheimer’s that has traditionally only been detectable through specialized brain scans or analysis of cerebrospinal fluid.

The Significance and Prevalence of Alzheimer’s Disease

Marty Makary, a commissioner at the U.S. Food and Drug Administration (FDA), emphasized the widespread impact of Alzheimer’s disease: “Alzheimer’s affects more people than breast cancer and prostate cancer combined.” He further highlighted the growing concern, stating that with 10% of individuals over 65 suffering from Alzheimer’s and this number expected to double by 2050, innovative medical products like this test could significantly aid patients.

Existing Treatments and Their Limitations

Currently, there are two FDA-approved treatments for Alzheimer’s: lecanemab and donanemab. These medications target amyloid plaques and have shown some success in slowing cognitive decline, though they do not cure the disease.

Advocates for intravenous antibody therapies, including many neurologists, argue that these treatments can provide patients with additional months of independence. Moreover, they suggest that such therapies might be more effective if initiated during the early stages of the disease.

Key Questions and Answers

  • What is the new blood test approved by the EU for? The new blood test has been approved to detect Alzheimer’s disease at its early stages.
  • Who developed this test? The test was developed by Fujirebio Diagnostics, a Japanese multinational company.
  • How does the test work? The test measures the proportion of two proteins in the blood, which correlates with amyloid plaques in the brain—a hallmark of Alzheimer’s.
  • Why is early detection important? Early detection allows patients to start treatment sooner, potentially slowing the progression of Alzheimer’s with newly approved medications.
  • What are the existing treatments for Alzheimer’s? The FDA has approved two medications, lecanemab and donanemab, which target amyloid plaques in the brain.
  • How effective are these treatments? While these medications have shown some success in slowing cognitive decline, they do not cure Alzheimer’s.
  • What do advocates for antibody therapies suggest? Advocates propose that initiating treatment during the early stages of Alzheimer’s with intravenous antibody therapies could provide patients with additional months of independence and potentially be more effective.