FDA clears first blood test to reliably predict Alzheimer's disease
The Food and Drug Administration (FDA) announced Friday it had cleared a new test to help diagnose adults with Alzheimer's disease, the first diagnostic tool that uses a blood draw to check for the illness.
The test is called the "Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio" and is developed by the Japanese company Fujirebio Diagnostics Inc. It measures specific biomarkers and proteins associated with Alzheimer's disease and amyloid plaque. Deposits of amyloid plaque in the brain are a hallmark of Alzheimer's.
Fujirebio submitted a regulatory filing with the FDA in September for its test. It is the first commercially available blood-based in vitro diagnostic test for assessing Alzheimer's in........
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