Early Alzheimer’s Test Gets FDA Nod

The first in vitro diagnostic tool to help detect early Alzheimer’s disease was authorized by the FDA on Wednesday.

The assay measures the ratio of beta-amyloid 1-42 to beta-amyloid 1-40 in cerebrospinal fluid (CSF). The Lumipulse G ß-Amyloid Ratio (1-42/1-40) test is intended to be used in adults 55 and older presenting with cognitive impairment who are being evaluated for Alzheimer’s disease or other causes of cognitive decline.

The FDA evaluated the safety and effectiveness of the Lumipulse test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative (ADNI) cohort, which were compared with amyloid PET scan results.

Overall, 97% of ADNI participants with positive Lumipulse results had the presence of amyloid plaques on PET, and 84% of individuals with negative Lumipulse results had a negative amyloid scan, the agency said.

Source: https://www.medpagetoday.com/neurology/alzheimersdisease/98558#:~:text=The%20first%20in%20vitro%20diagnostic,in%20cerebrospinal%20fluid%20(CSF)