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FDA permits marketing of first in vitro diagnostic test for Alzheimer's disease

DTMT Network

The United States Food and Drug Administration (FDA) said recently that it has permitted the marketing of the first in vitro diagnostic test for early detection of amyloid plaques associated with Alzheimer’s disease.

The test, called Lumipulse G β-Amyloid Ratio (1-42/1-40) test is intended to be used in adult patients, aged 55 years and older, presenting with cognitive impairment who are being evaluated for Alzheimer’s disease and other causes of cognitive decline, FDA  said in an official release on May 4, 2022.

 “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,” director of the FDA’s Center for Devices and Radiological Health, Dr Jeff Shuren said.

“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,”  he added.

The Lumipulse test is intended to measure the ratio of β-amyloid 1-42 and β-amyloid 1-40 (specific proteins that can accumulate and form plaques) concentrations found in the human cerebral spinal fluid (CSF), which can help physicians determine whether a patient is likely to have amyloid plaques, a hallmark sign of Alzheimer’s disease, the FDA statement read.

The FDA said that it evaluated the safety and effectiveness of this test in a clinical study of 292 CSF samples from the Alzheimer’s Disease Neuroimaging Initiative sample bank, wherein the samples were tested by the Lumipulse G β-amyloid Ratio (1-42/1-40) and compared with amyloid PET scan results.

In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio (1-42/1-40) positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan, the drug regulator added.

 
    

 


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