Cerebrospinal Fluid Amyloid Tests A Step Closer to Use in Day-to-Day Practice 

An application has been made to the Food and Drug Administration (FDA) for clearance of a device (Lumipulse G1200; Fujirebio Diagnostics, Malvern, PA), already granted breakthrough designation by the FDA, for measurement of amyloid-ß ratios in cerebrospinal fluid (CSF). If cleared, this would be among the first commercially available diagnostic tests for the presence of amyloid plaques in the brain, for which the ratio of amyloid-ß42 to amyloid-ß40 is a validated measure. If approved, the test could aid in earlier and potentially presymptomatic or mild Alzheimer disease and other causes of brain amyloid plaques.

Earlier diagnosis can lead to earlier lifestyle modifications including diet and exercise, which are known to decrease risk of dementia, and addressing any glucose dysregulation, known to increase the risk dementia. Early diagnosis will also aid in identifying individuals who may be able to take part in clinical trials as new treatments are being developed. Additionally, early diagnosis allows people to be treated at the first sign of symptoms rather than waiting until the disease has further progressed.

“The lack of effective and accessible clinical tools for patients who could be on the pathway to develop Alzheimer’s disease contributes to its late diagnosis and inadequate treatment,” says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. “We designed our Lumipulse G Amyloid Ratio test to help physicians triage their patient much sooner when effective interventions are more feasible using these well-researched amyloid biomarkers. Accurate and earlier intervention will also facilitate the development of new drug therapies, which are urgently needed as the prevalence of Alzheimer’s disease increases with a rapidly aging population globally.”

CSF amyloid ratio and tau tests with the device have already been cleared for use in the European Union.