Topline
The first blood test used to diagnose Alzheimer’s disease was cleared by the Food and Drug Administration for marketing Friday, meaning the laboratory test can be marketed and sold in the U.S., a significant benchmark for detection of the brain disorder that affects 10% of people aged 65 and older.
The clearance was announced Friday afternoon. (AP Photo/Jacquelyn Martin, File)
Key Facts
The diagnostic device that tests blood to help diagnose Alzheimer’s was developed by Fujirebio, a Japanese biotechnology company.
Unlike the newly cleared blood test device, other FDA-authorized or cleared Alzheimer’s tests instead used cerebrospinal fluid samples from patients collected through spinal taps—invasive procedures involving the puncture of the lumbar.
Top FDA official Michelle Tarver said the clearance makes Alzheimer’s diagnosis “easier and potentially more accessible for U.S. patients earlier in the disease.”
An FDA study found the blood test “can reliably predict” the presence of protein conditions associated with Alzheimer’s at the time of the test in cognitively impaired patients.
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Big Number
6.7 million. That is the estimated number of Americans who have Alzheimer’s in the U.S., according to the Centers for Disease Control and Prevention, which notes that number is expected to double by 2060.
Surprising Fact
As of now, the lifetime risk for Alzheimer’s for people aged 45 is one in five for women and one in 10 for men.
Key Background
Alzheimer’s diagnosis can be a lengthy process consisting of memory testing, laboratory tests, brain-imaging examinations and more. The Alzheimer’s Association has said the increase in blood tests for the disease could make for earlier and more accurate detection and diagnosis, potentially taking precedent over standard methods that are “expensive, invasive and not always accessible.” Costs for people with dementia, which Alzheimer’s is a form of, are projected to reach $384 billion this year and nearly $1 trillion by 2050. Up and coming blood tests could also help recruitment for Alzheimer’s clinical trials and cut down wait times for disease assessment. Healthcare experts have contributed the forecasted dramatic increase in Alzheimer’s to an increase in the aging population and improved diagnosis.
Further Reading
Latest Alzheimer’s lab tests focus on memory loss, not brain plaques (NPR)
Alzheimer’s blood test catches 90% of early dementia cases, study finds (CNN)
Source: https://www.forbes.com/sites/antoniopequenoiv/2025/05/16/fda-greenlights-blood-test-to-diagnose-alzheimers-the-first-of-its-kind/