FDA approves marketing for new Alzheimer's early detection test

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FDA approves marketing for new Alzheimer's early detection test
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The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is available at clinical laboratories nationwide for adult patients aged 55 years and older who are presenting with cognitive impairment and being evaluated for Alzheimer’s disease and other causes of cognitive decline.

The test, which is developed by Fujirebio Diagnostics Inc., is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 proteins found in human cerebral spinal fluid, which can help physicians determine whether a patient is likely to have amyloid plaques. β-amyloid plaques are believed to contribute to the loss of cognitive function that characterizes Alzheimer's disease.

Prior to the marketing authorization, doctors used positron emission tomography scans, a potentially costly and time-consuming option, to detect and visualize amyloid plaques in a patient’s brain and help diagnose Alzheimer's disease years before clinical symptom onset.

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