Fujirebio's Lumipulse Test for Alzheimer’s Disease

On May 16, 2025, Fujirebio Diagnostics, Inc. received FDA approval for its Lumipulse^® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD). 

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio measures two proteins, pTau 217 and β-Amyloid 1-42 concentrations in human plasma. The test then calculates a numerical ratio of pTau 217/β-Amyloid 1-42. This ratio is correlated to the presence or absence of amyloid plaques in the brain that are associated with Alzheimer’s disease. 

FDA evaluated the results of a multi-center clinical trial of 499 individual plasma samples from adults who were cognitively impaired. The samples were tested by the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio and the results were compared with amyloid PET scan or CSF test results.  In this study, 91.7% of individuals with Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio positive results had the presence of amyloid plaques by PET scan or CSF test result, and 97.3 % of individuals with negative results had a negative amyloid PET scan or CSF test result. Less than 20% of the 499 patients tested had an indeterminate Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio result.

These findings indicated that the new blood test can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients who are cognitively impaired. 

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio is intended for patients aged 55 years and older who present at a specialized care setting with signs and symptoms of cognitive decline. The results must be interpreted in conjunction with other patient clinical information.

Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio should not be used for screening of asymptomatic individuals or as a stand-alone diagnostic test.

Reference

FDA News Release, FDA Clears First Blood Test Used in Diagnosing Alzheimer’s Disease: New Test Provides Less Invasive Option, Reduces Reliance on PET Scans and Increases Diagnosis Accessibility, May 16, 2025.