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 awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 ...

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

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

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 FDA cleared the test for early detection of amyloid plaques associated with Alzheimer’s in people aged 55 years and older ...

The test is for those aged 55 and older who are already exhibiting signs and symptoms of the disease, the FDA says.

The US Food and Drug Administration (FDA) has awarded 510(k) clearance to Fujirebio’s Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio in vitro diagnostic (IVD) test for evaluating amyloid ...

U.S. regulators have approved the first blood test to help diagnose Alzheimer’s disease, potentially making it easier to find ...

Patients now have an alternative. The FDA has cleared a new Fujirebio Diagnostics test that detects signs of the disease from a sample of patient blood, marking what the agency says is the first ...