A Groundbreaking Alzheimer's Blood Test Is Now FDA-Approved
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The test may make it easier to identify whether people with memory and thinking problems have Alzheimer’s or not.
Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer’s disease and other causes of cognitive decline.
Today, the FDA's approved the Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio, marking a pivotal moment in the fight against Alzheimer's disease. This is the first blood test authorized to aid in the diagnosis of Alzheimer's—ushering in a new era of care,