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 for Alzheimer’s disease (AD) and other causes of cognitive decline. 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.
