The FDA has cleared the first lab diagnostic test to aid in the early detection of Alzheimer's disease.
May 5, 2022 – The FDA has cleared the first in vitro diagnostic to aid in the early detection of Alzheimer's disease .
"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 said. The Lumipulse test measures the ratio of β-amyloid 1-42 and β-amyloid 1-40 concentrations in human cerebral spinal fluid . A positive Lumipulse G β-amyloid Ratio test result is consistent with the presence of amyloid plaques, similar to that revealed in a PET scan. A negative result is consistent with a negative amyloid PET scan result.
The samples were tested by the Lumipulse G β-amyloid Ratio and compared with amyloid PET scan results. In this clinical study, 97% of individuals with Lumipulse G β-amyloid Ratio positive results had the presence of amyloid plaques by PET scan and 84% of individuals with negative results had a negative amyloid PET scan.
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