The US Food and Drug Administration (FDA) has approved the first blood test to diagnose Alzheimer’s disease, paving the way for earlier detection and treatment of this neurological condition. Developed by Fujirebio, the test is a more affordable alternative to PET scans or spinal taps currently used for diagnosis.
Alzheimer’s affects over 7 million Americans over age 65, with cases continuing to rise. Early diagnosis allows patients to access new drugs that can slow disease progression. The blood test detects amyloid plaques in the brain, which are typically identified via costly PET scans or invasive spinal taps.
In a clinical trial, the blood test was successful in detecting amyloid plaques in over 90% of cognitively impaired individuals, with fewer than 20% of patients receiving inconclusive results. However, the FDA noted that false positive or negative results are possible and that the test should be used in conjunction with other clinical information.
The approval marks a significant step forward in Alzheimer’s diagnosis and treatment, with potential benefits for patients and healthcare providers alike.
Source: https://www.axios.com/2025/05/16/fda-clears-alzheimers-blood-test