Topline
The first blood test used to diagnose Alzheimer’s disease was cleared by the Food and Drug Administration for marketing Friday, meaning the laboratory test can be marketed and sold in the U.S., a significant benchmark for detection of the brain disorder that affects 10% of people aged 65 and older.
The clearance was announced Friday afternoon. (AP Photo/Jacquelyn Martin, File)
The diagnostic device that tests blood to help diagnose Alzheimer’s was developed by Fujirebio, a Japanese biotechnology company.
Unlike the newly cleared blood test device, other FDA-authorized or cleared Alzheimer’s tests instead used cerebrospinal fluid samples from patients collected through spinal taps—invasive procedures involving the puncture of the lumbar.
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