The U.S. Food and Drug Administration (FDA) has approved the first blood-based test to help diagnose Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, developed by Fujirebio Diagnostics, Inc., is intended for adults aged 55 and older showing signs of cognitive decline. The test measures two specific proteins in the blood to detect the presence of amyloid plaques, a key indicator of Alzheimer’s, making diagnosis less invasive than current methods like PET scans or spinal taps. The FDA granted this test Breakthrough Device status and cleared it via the 510(k) process, finding it comparable to an earlier test that uses spinal fluid rather than blood.
Confidently diagnosing Alzheimer’s disease is difficult and requires a multifaceted exam that includes ascertaining information about family history, physical and cognitive testing, as well as brain scans that rule out other conditions. However, it may now be easier to diagnose Alzheimer’s considering the FDA just approved the first blood test to diagnose Alzheimer’s disease. The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio (Lumipulse G assay) developed by Fujirebio Diagnostics Inc. is for the early detection of amyloid plaques associated with Alzheimer’s disease in adult patients, aged 55 years and older, exhibiting signs and symptoms of the disease. In a clinical study testing the efficacy of the assay, plasma was collected from 499 individuals with cognitive impairments and tested. Of those individuals who had a positive Lumipulse G assay, 91.7% showed positive results with the Lumipulse G assay that correlated to the presence of amyloid plaques by PET scan or CSF test results, and 97.3% with negative results had a negative amyloid PET scan or CSF result. Less than 20% of the 499 patients received an inconclusive Lumipulse G assay. The biggest risk associated with the Lumipulse G assay is a false positive resulting in the unnecessary treatment of Alzheimer’s disease.