Fujirebio recently announced that the US Food and Drug Administration (FDA) has granted clearance for the company’s Lumipulse in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in ...

The FDA approved a test that can help clinicians diagnose Alzheimer's disease early on using a simple blood draw. The test ...

A first-of-its-kind blood test developed by Malvern-based Fujirebio Diagnostics to help diagnose Alzheimer’s disease has ...

The blood test is used to detect abnormal protein deposits in the brain that are associated with Alzheimer's. The test is for people 55 and older who are already showing signs of the disease, ...

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

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 ...

Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company’s ...

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

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 granted 510(k) marketing clearance to the first in vitro blood-based biomarker diagnostic device for Alzheimer’s ...

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 ...