The U.S. Food and Drug Administration on Friday cleared the first blood test for the diagnosis of Alzheimer's disease.
FDA clearance means the test may now be marketed and sold in the U.S. It will be used for patients 55 or older who are showing symptoms of Alzheimer's.
The test, by manufacturer Lumipulse, measures blood samples for the presence of telltale proteins that appear in blood plasma in certain ratios depending on whether there are amyloid plaques present in the brain.
These plaques are a hallmark indicator of Alzheimer's disease.
The new blood test stands to be less invasive and expensive than existing screening methods, some of which detected plaques by radioactive imaging or required drawing cerebrospinal fluid from the lower spine.
In earlier trials that compared its performance with the older screening tests, Luminpulse's new blood test was more than 91% successful in detecting the presence of Alzheimer's and more than 97% successful in showing its absence.
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Some 10% of people over the age of 65 develop Alzheimer's, a rate that experts expect to increase to as much as double by 2050.
“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” said Dr. Michelle Tarver, director of the FDA's Center for Devices and Radiological Health. “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.”
