The US Food and Drug Administration (FDA) has approved the first blood test to diagnose Alzheimer’s disease, providing a faster and more accessible way for patients to receive detection and treatment. Developed by Japan-based Fujirebio Diagnostics, the test detects amyloid plaques in the brain using a blood sample.
Nearly 7 million Americans are living with Alzheimer’s, a number projected to rise to nearly 13 million. The current method of detecting amyloid involves PET imaging scans or spinal fluid tests, which can be inconvenient and costly. The new blood test aims to improve diagnosis, making it easier for U.S. patients to receive treatment earlier in the disease.
Biogen and Eisai market the Alzheimer’s treatment Leqembi, while Eli Lilly sells Kisunla. Both companies welcome the FDA’s approval, seeing it as a step forward in improving access to timely diagnosis. Professor Jason Karlawish of the University of Pennsylvania notes that the test has the potential to improve the diagnostic experience but warns about the risk of “frisky prescribing habits” if not used properly.
The test measures two proteins in human plasma and correlates their levels to the presence or absence of amyloid plaques in the brain. In a clinical study, 92% of individuals with positive blood-test results had amyloid plaques confirmed by PET scan or spinal-fluid test, while 97% of those with negative results also had confirmed negative results using other methods.
The approval marks a significant breakthrough in Alzheimer’s disease diagnostics and is expected to have a positive impact on patient care.
Source: https://www.statnews.com/2025/05/16/alzheimers-fujirebio-fda-approval