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News

Alzheimer's, Fujirebio and FDA

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Fujirebio Alzheimer’s test wins first FDA clearance
Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the debilitating neurodegenerative disease. Fujirebio’s Lumipulse G pTau217/ß-Amyloid 1-42 plasma ratio is indicated for the early detection of amyloid plaques associated with Alzheimer’s disease in symptomatic individuals aged 55 years and older.

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BioWorld · 5h
Medical Device Network on MSN · 19h
FDA grants 510(k) clearance to Fujirebio’s blood-based test for Alzheimer’s
Best Life on MSN · 11h
FDA Approves First-Ever Alzheimer's Blood Test—Here's Who Will Benefit
2d
FDA clears first blood test to diagnose Alzheimer’s disease
U.S. regulators have approved the first blood test to help diagnose Alzheimer’s disease, potentially making it easier to find ...
MyChesCo on MSN3d
Fujirebio and AriBio Achieve Milestone in Biomarker Advancement for Alzheimer’s Disease
Fujirebio Holdings Inc., its subsidiary Fujirebio Diagnostics, Inc., and AriBio Co., Ltd. have announced the successful ...

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