The U.S. Food and Drug Administration (FDA) has announced a historic approval for the first blood test designed to aid in the diagnosis of Alzheimer’s disease, marking a major shift in detecting this memory-destroying neurodegenerative disorder.

Simpler diagnosis instead of complex procedures

The test, called “Lumipulse,” targets individuals aged 55 and older who show early signs of cognitive decline.

It works by measuring specific proteins in the blood, most notably Beta-Amyloid and phospho-Tau 217 (pTau217), which are key biomarkers associated with the plaques and tangles characteristic of Alzheimer’s in the brain.

Previously, detecting these biomarkers required:

• Positron Emission Tomography (PET) scans: expensive and requiring specialized equipment.
• Cerebrospinal fluid analysis: an invasive procedure considered more intrusive and uncomfortable for patients.

Significance and accuracy of the test

Clinical trials indicate that the blood test results closely match those of more complex tests, with over 90% accuracy in detecting Alzheimer’s-related changes.

The new test is expected to revolutionize early diagnosis, allowing patients to begin treatments such as Leqembi and Donanemab, which can slow cognitive decline in its early stages.

Experts emphasize that the test is not a definitive diagnosis on its own but should be used as part of a comprehensive clinical evaluation that includes the patient’s medical history and additional cognitive assessments.