Posted on 5/10/2022
The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA-authorized in vitro diagnostic test in the U.S. to aid in the assessment of Alzheimer’s disease and other causes of cognitive decline.
MALVERN, Pa., USA - Fujirebio Diagnostics, Inc., a consolidated subsidiary of H.U. Group Holdings, Inc., today announced that the U.S. Food and Drug Administration (FDA) has granted De Novo marketing authorization for the company’s Lumipulse® G β-Amyloid Ratio (1-42/1-40) in vitro diagnostic (IVD) test for the assessment of β-Amyloid pathology in patients being evaluated...