FDA permits marketing for new test to improve diagnosis of Alzheimer’s disease

FDA

4 May 2022 - The U.S. FDA today permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease. 

The Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline.

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , US , Device