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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 Inc., a unit of Japan’s H.U. Group Holdings Inc., 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.



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