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First blood test to diagnose Alzheimer’s disease approved in the US
The US Food and Drug Administration (FDA) on Friday, May 16, 2025, cleared the sale of the first device to analyze blood in order to diagnose Alzheimer’s disease. The test, developed by Fujirebio Diagnostics, measures the ratio of two proteins in the blood. This ratio correlates with the amount of amyloid plaques in the brain – protein clumps that damage brain cells and cause memory loss. Previously, β-amyloid plaques, the elements that occur in Alzheimer’s disease, could only be detected by brain imaging or cerebrospinal fluid analysis.
“Alzheimer’s disease affects a lot of people – more than breast cancer and prostate cancer combined,” said Food and Drug Administration Commissioner Marty Makary. One in 10 people over the age of 65 is known to have Alzheimer’s disease, and that number is expected to double by 2050. The test, called Lumipulse G pTau217/ β-Amyloid 1-42 Plasma Ratio, is designed for adults over the age of 55 who have symptoms of Alzheimer’s disease (the most common being sleep disturbance, memory loss, social isolation, speech impairment, pelvic organ dysfunction, personality changes, and trouble reading or doing basic math).
The test works by measuring two proteins in plasma: pTau217 and β amyloid 1-42. The ratio of these proteins generally correlates with the presence or absence of amyloid plaques in the brain. The test does not determine the amount of amyloid directly, but can signal its presence. In clinical trials, the results of the blood test were more than 90% consistent with the results of positron emission tomography (PET) brain scans and cerebrospinal fluid analysis. The FDA said the results of the new test should be evaluated solely in conjunction with clinical information about the patient’s condition.
According to the Alzheimer’s Association, there are many tests on the market that can be used to detect blood biomarkers associated with Alzheimer’s disease, but Fujirebio Diagnostics’ invention is the first to receive official approval.
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