FDA Permits Marketing For First In-Vitro Spinal Fluid Test To Improve Diagnosis Of Alzheimer’s Disease

On May 4, 2022, the U.S. Food and Drug Administration (FDA) granted Fujirebio Diagnostics, Inc. marketing authorization for its Lumipulse G β-Amyloid Ratio (1-42/1-40) test used with cerebral spinal fluid (CSF) samples to detect amyloid proteins associated with Alzheimer’s disease. The test can be used by primary care professionals (PCPs) to evaluate adults age 55 and older who are experiencing cognitive problems for Alzheimer’s disease and other causes of cognitive decline.

The test reports the ratio of β-amyloid 1-42 and β-amyloid 1-40, two proteins associated brain amyloid plaques that are a hallmark . . .