Developers: | Fujirebio Diagnostics |
Date of the premiere of the system: | May 2022 |
2022: Release of the world's first test for early detection of Alzheimer's disease, which can be used by conventional medical laboratories
In May 2022, it became known about the entry into the market of the first in vitro test (can be done in ordinary medical laboratories), which will help determine whether people with signs of cognitive decline have one of the hidden signs of Alzheimer's disease. Diagnosis reveals amyloid plaques in samples of cerebrospinal fluid.
The Lumipulse test, developed by Fujirebio Diagnostics, is designed for patients aged 55 years and older. The agency said that with the advent of this diagnosis, some patients will be able to avoid expensive PET brain scans - a standard method for detecting amyloid protein clots associated with neurodegenerative disease.
With the Lumipulse test, there is a new opportunity that can typically be implemented on the same day and can give doctors the same information about the state of brain amyloid without the risk of radiation to help determine whether a patient's cognitive impairment is caused by Alzheimer's disease, said FDA Center for Food and Drug Control Director Jeff Schuren in a statement. |
Negative results reduce the likelihood that a person's cognitive impairment is caused by Alzheimer's disease, allowing doctors to focus on other causes of declining health and dementia.
Patients, doctors and families now have a valuable new tool to identify people whose early symptoms may indicate Alzheimer's disease, allowing for lifestyle change and possibly access to new treatments aimed at slowing or stopping the progression of the disease. said Mont Wiltse, president and CEO of Fujirebio, which predicts the number of Alzheimer's cases in the U.S. will reach 14 million by 2050.[1]