FDA permits marketing for new in vitro Alzheimer’s disease test
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The FDA granted breakthrough device designation and permitted marketing for the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.
Developed by Fujirebio Diagnostics, the Lumipulse G β-Amyloid Ratio test is intended for adults, aged 55 years and older, presenting with cognitive impairment who are being evaluated for AD and other causes of cognitive decline.
“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,” Jeff Shuren, MD, JD, director of the FDA Center for Devices and Radiological Health, said in a released statement.
According to the NIH, more than 6 million Americans aged 65 years and older may have dementia caused by AD. In most people with Alzheimer’s, symptoms present later in life.
Although amyloid plaques can occur in other diseases, the detection of plaques can help clinicians determine the probable cause of a patient’s symptoms. Before authorization of this new diagnostic test, physicians relied solely on PET scans, which can be costly.
“With the Lumipulse test, there is a new option that can typically be completed the same day and can give doctors the same information regarding brain amyloid status, without the radiation risk, to help determine if a patient’s cognitive impairment is due to Alzheimer’s disease,” Shuren said.
According to the release, the Lumipulse test measures the ratio of beta-amyloid 1-42 and beta-amyloid 1-40 — specific proteins that can accumulate and form plaques —found in cerebrospinal fluid. A positive test result is consistent with the presence of amyloid plaques, similar to what would be observed in a PET scan. However, a positive test result can also be seen in those with other types of neurologic conditions, emphasizing the importance of using this test in combination with other diagnostics.
The FDA assessed the safety and efficacy of the test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative bank, which were evaluated using the Lumipulse test and compared with amyloid PET scan results. According to the study, 97% of participants with a Lumipulse positive result had the presence of amyloid plaques via PET scan, and 84% of participants with negative results had a negative PET scan.