The first blood test to detect Alzheimer’s disease Cleared by the US Food and Drug Administration (FDA).
In a press release Friday, the agency announced approval for its first Vitro diagnostic device, Lumipulse.
This method is intended to detect early Alzheimer’s disease in adult patients Over 55 years old People with signs and symptoms of illness.
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New technologies work by detecting Amyloid plaque in the brainsigns of Alzheimer’s disease.
The first ever blood test to detect Alzheimer’s disease has been cleared by the US Food and Drug Administration. (istock)
According to the FDA, PET scans can pick up these plaques, but they can be “expensive and time-consuming” while exposing patients to radiation.
The new Lumipulse device reduces the need for PET scans and other invasive testing, the agency said.
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in Clinical research Of the 499 plasma samples from adults with cognitive impairment, the Lumipulse test detected the presence of amyloid plaque in 91.7% of individuals.
The results show that new blood tests can reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease when testing patients with cognitive impairment,” the FDA concluded.
According to the FDA, the new technology works by detecting amyloid plaques in the brain for signs of Alzheimer’s disease. (istock)
The FDA focuses on the risk of false positive results from Lumipulse, and has also made it possible to diagnose inappropriately. No need treatment.
“Alzheimer’s disease affects too many people,” FDA Commissioners Marty McCurry, MD and MPH said. breast cancer Prostate cancer was combined. ”
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“We hope that new medical products like this will help patients, knowing that 10% of people over 65 have Alzheimer’s disease and that by 2050, we will be able to double that number,” he said.
“Today’s clearance is an important step in the diagnosis of Alzheimer’s disease, making it easier and potentially accessible to patients in the US early in the disease,” the expert commented. (istock)
Center for Devices and Radiation Health Directors Michel Terber, MD and PhD also commented in a press release that nearly 7 million Americans live with Alzheimer’s.
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“And this number is projected to rise to almost 13 million,” she said.
“Today’s clearance is an important step in the diagnosis of Alzheimer’s disease, making it easy and potentially accessible to patients in the US early in the disease.”
