Fujirebio Diagnostics has secured the US Food and Drug Administration (FDA) approval to commercialise its test for early detection of amyloid plaques associated with Alzheimer’s disease.
The Lumipulse G β-Amyloid Ratio (1-42/1-40) test, said to be the first-of-its-kind in vitro diagnostic test, is intended for use in adult patients of age 55 or more, suffering from cognitive impairment and are being tested for Alzheimer’s disease.
It measures the ratio of β-amyloid 1-42 to -amyloid 1-40 concentrations in the human cerebral spinal fluid (CSF), which can assist clinicians in assessing whether a patient is likely to have amyloid plaques or not.
FDA Center for Devices and Radiological Health director Jeff Shuren said: “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.
“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.”
The US FDA measured the safety and effectiveness of the test by conducting a study of 292 CSF samples and comparing the results with amyloid PET scan results.
In the study, 97% of people 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.
FDA mentioned that the Lumipulse G β-amyloid Ratio (1-42/1-40) is not a stand-alone test and other clinical evaluations or additional tests should be used for determining treatment options.
The device was assessed by the FDA through the De Novo premarket review process, which is a regulatory procedure for low- to moderate-risk new-type devices.
It also received Breakthrough Device designation from FDA to expedite the development and evaluation of the system.
