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

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

Other diagnostic companies have developed similar blood-based tests for Alzheimer’s, but the one from Fujirebio is the first to receive clearance from the FDA. In a clinical study, 92% of ...

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

The Food and Drug Administration (FDA) announced Friday it had cleared a new test to help diagnose adults with Alzheimer’s ...

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 ...

Not all people should take Fujirebio's new test. The FDA says that it is "intended for patients presenting at a specialized care setting with signs and symptoms of cognitive decline" and is ...

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.