The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...

Japan-based Fujirebio's test, which helps doctors diagnose Alzheimer's disease, is intended for patients with signs of ...

The US Food and Drug Administration (FDA) has approved Fujirebio Diagnostics’ Alzheimer’s disease (AD) blood test to help ...

The FDA said it has issued its first official green light for a blood test to help diagnose Alzheimer’s disease, adding that ...

The test may make it easier to identify whether people with memory and thinking problems have Alzheimer’s or not.

Fujirebio Diagnostics Inc.’s Alzheimer’s disease assay received the U.S. FDA’s first clearance for a blood test for the ...

The FDA has cleared the first blood test to diagnose Alzheimer's which works by measuring the amount of pTau 217 and ...

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s Lumipulse ® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) ...

The approval comes as two Alzheimer's drugs—lecanemab and donanemab—are already authorized by the FDA. Both are antibody therapies that target amyloid plaques and are believed to be more effective ...

The U.S. Food and Drug Administration has cleared Fujirebio Diagnostics' blood test to diagnose Alzheimer's disease, the ...

The Food and Drug Administration has cleared the blood test to help diagnose Alzheimer's disease, potentially making it ...

The first Alzheimer's blood test cleared by the Food And Drug Administration is poised to change the way doctors diagnose and ...