FDA Permits Marketing For New Lumipulse G β-Amyloid Ratio Test to Improve Diagnosis Of Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has 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 adults, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline. The FDA permitted marketing of the Lumipulse G ß-Amyloid Ratio (1-42/1-40) to Fujirebio Diagnostics, Inc.

The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 . . .