Fujirebio
Fujirebio Alzheimer's Test Approval Offers Alternative to Imaging, Could Speed Plasma Marker Efforts
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The test, which measures β-amyloid in cerebrospinal fluid, received FDA de novo classification, making it the first IVD available for detection of brain amyloid plaques.
Fujirebio Gets FDA De Novo Classification for Lumipulse Alzheimer's Test
The test is the first in vitro diagnostic the FDA has allowed to be marketed for the early detection of the amyloid plaques associated with Alzheimer's disease.
The approval of Biogen's Alzheimer's disease treatment in June was seen as an important regulatory development for companies developing tests.Â
In Brief This Week: PerkinElmer, Fujirebio Europe, Exagen, Genetic Technologies, and More
News items for the in vitro diagnostics industry for the week of Oct. 25, 2021.
Norwegian Startup Pre Diagnostics Developing Monocyte Test for Presymptomatic Alzheimer's Disease
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The firm said its test detects biomarkers inside monocyte blood cells that reflect the reduced clearance of amyloid-beta plaque that leads to Alzheimer's disease.