New blood test for Alzheimer’s approved by FDA

On Friday, the U.S. Food and Drug Administration approved a new blood test for detecting Alzheimer’s disease early in patients with cognitive decline. Fujirebio Diagnostics, a company focusing on medical diagnostic products, has received FDA clearance to market the test called Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio. Dr. Michelle Tarver, from the Center for Devices and Radiological Health, highlighted the importance of this approval for Alzheimer’s diagnosis, especially with the growing number of affected individuals in the U.S.

The blood test examines the ratio of two proteins in the patient’s blood plasma, indicating the presence of amyloid plaques in the brain, a key characteristic of Alzheimer’s disease. Previously, confirming these plaques required expensive PET brain scans or invasive spinal taps, making the new blood test a more affordable and safer option for patients. The FDA reviewed data from a study involving 499 plasma samples from cognitively impaired adults to validate the accuracy of the blood test compared to PET scans or spinal taps.

Results showed that the blood test accurately identified Alzheimer’s-related plaques 92% of the time when present and ruled out their presence 97% of the time when absent. The FDA stated that this new test can effectively predict the presence or absence of Alzheimer’s-related amyloid pathology at the time of testing in patients with cognitive decline. The test is designed for use in specialized care settings for patients showing signs of cognitive impairment, and the results should be considered along with other clinical information.