FDA Clears First Blood Test Used In Diagnosing Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) approved Lumipulse, the first blood test to help diagnose Alzheimer’s disease. The test was developed by Fujirebio Diagnostics, Inc., for early detection of amyloid plaques associated with Alzheimer’s disease in adults aged 55 years and older who are exhibiting signs and symptoms of the disease. The test provides a less invasive option to diagnose Alzheimer's disease, compared with positron emission tomography (PET) brain scans, or spinal taps.

The test is formally called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. The FDA granted it Breakthrough Device Designation. The . . .