The first in vitro diagnostic test to detect brain plaques tied to Alzheimer’s disease can now be marketed to clinicians, the Food and Drug Administration announced this week.
The Lumipulse G β-Amyloid Ratio test is indicated for use in adults aged 55 years and older with cognitive decline. It analyzes spinal fluid to evaluate proteins that can accumulate and form brain amyloid beta plaques that are a hallmark sign of Alzheimer’s.
The test can be completed the same day and may be a more convenient alternative to the commonly used positron emission tomography (PET) brain scans when diagnosing disease, the agency said. Doctors receive the same information on brain amyloid status as they would with a PET scan, without the radiation risk, Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health, said in a statement.
“The availability of an in vitro diagnostic test that can potentially eliminate the need for time-consuming and expensive PET scans is great news for individuals and families concerned with the possibility of an Alzheimer’s disease diagnosis,” he said.
The test should not be used as a stand-alone diagnostic assay. Positive results may also indicate other types of neurologic conditions. Signs of brain plaques may also be detected in cognitively healthy older people. These facts underscore the importance of using Lumipulse in conjunction with other clinical evaluations to make a final diagnosis, the FDA cautioned.