FDA approves the use of the first blood test to detect Alzheimer's
The test, developed by Japanese company Fujirebio Diagnostics, measures the ratio of two proteins in the blood. This ratio correlates with amyloid plaques in the brain, a hallmark of Alzheimer's that until now could only be detected by specially scanned brain imaging or cerebrospinal fluid analysis.
FDA building.
The U.S. Food and Drug Administration (FDA) cleared the use of the first blood test to detect Alzheimer's. It is a decision that could help patients start treatment earlier with newly approved drugs that slow the progression of this the neurological disease.
"Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients," explained Martin A. Makary, FDA commissioner.
The test, developed by Japanese company Fujirebio Diagnostics, measures the ratio of two proteins in the blood.
This ratio correlates with amyloid plaques in the brain, a hallmark of Alzheimer's that until now could only be detected by specially scanned brain imaging or cerebrospinal fluid analysis.
According to the FDA, about 7 million Americans are living with Alzheimer's disease, and that number is projected to rise to nearly 13 million.
"Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease," detailed Michelle Tarver, director of the Center for Devices and Radiological Health.
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