First blood test for the diagnosis of Alzheimers eliminated by the FDA
The first blood test to detect Alzheimer’s disease has been cleared by the United States Food and Medicines Administration (FDA).
In a press release on Friday, the agency announced its approval of the first in vitro diagnostic device, Lumipulse.
The method is intended for the early detection of Alzheimer’s in adult patients over 55 years of age who exhibit signs and symptoms of the disease.
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The new technology works detecting amyloid plates in the brain, a revealing Alzheimer’s sign.
The first blood test to detect Alzheimer’s disease has been clear by the United States Food and Medicines Administration. (Istock)
While PET scans can collect these plates, they can be “expensive and slow” while exposing patients to radiation, according to FDA.
The new lumipulse device reduces the need for a PET exploration or other invasive tests, the agency said.
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In a clinical study of 499 adult plasma samples with disabilities cognitively, the lumipulse test detected the presence of amyloid plaques in 91.7% of individuals.
The results indicate that the new blood test can “reliably predict the presence or absence of amyloid pathology associated with Alzheimer’s disease at the time of the test in patients with cognitively disabilities,” the FDA concluded.
The new technology works detecting amyloid plates in the brain, a revealing Alzheimer’s sign, according to the FDA. (Istock)
The FDA pointed out the risk of results of False Positive Lumipulse test, which could lead to an inappropriate diagnosis and unnecessary treatment.
The FDA Commissioner Marty Makary, MD, MPH, wrote in a statement: “Alzheimer’s disease affects too many people, more than breast cancer and combined prostate cancer.”
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“Knowing that 10% of people 65 years of age or older have Alzheimer’s, and that by 2050 this number is expected to double, I hope that new medical products like this will help patients,” he said.
“Current authorization is an important step for the diagnosis of Alzheimer’s disease, which makes it easier and more accessible to US patients before the disease,” said an expert. (Istock)
The Devices Center and Radiological Health Director Michelle Trver, MD, PHD, also commented in the press release that almost seven million Americans live with Alzheimer’s.
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“And it is projected that this number increases to almost 13 million,” he said.
“Current authorization is an important step for the diagnosis of Alzheimer’s disease, which makes it easier and more accessible to US patients before the disease.”
Angelica Stabile is a lifestyle reporter for News Digital.