FDA approves blood test to diagnose Alzheimer’s
The US Food and Drug Administration (FDA) has approved the first blood test for diagnosing Alzheimer’s disease.1 The test, called Lumipulse, was granted breakthrough device approval and is designed for early detection of amyloid plaques associated with Alzheimer’s disease in patients aged over 55 who exhibit signs and symptoms of the disease. Made by Fujirebio Diagnostics, the test measures the ratio between two proteins (pTau17 and beta-amyloid 1-42) in human plasma. The ratio is related to the presence of amyloid plaques in the brain that are thought to be linked to …