FDA clears first blood test to diagnose Alzheimer's disease
U.S. regulators have approved the first blood test to help diagnose Alzheimer's disease, potentially making it easier to find and treat patients with the mind-robbing disease that affects nearly 7 million Americans.
The test made by Fujirebio Diagnostics, a unit of Japan's H.U. Group Holdings, was cleared for people 55 years and older who exhibit signs and symptoms of the disease, the U.S. Food and Drug Administration said in a statement. It is designed for the early detection of amyloid, a protein that can build up in the brain and is a hallmark of Alzheimer's, the most common form of dementia in the elderly.
The development and approval of blood tests that can spot which patients are likely to have toxic amyloid in their brains has been viewed as a critical step toward making drugs to treat the condition more widely accessible. While the test is approved for people who are already exhibiting signs of cognitive impairment, studies show amyloid begins accumulating in the brains of some patients years before symptoms begin.
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