The US Food and Drug Administration (FDA) has authorized the marketing of a blood test to assist in the diagnosis of Alzheimer’s disease, making it the first to receive approval to help early detection of the disease in the United States.
The test, called Lumulturse G PTAU217/ß-Amyloid 1-42 plasma ratio, is intended for adults 55 years or older with signs and symptoms of Alzheimer’s disease, FDA announced on Friday.
It works by measuring two proteins in blood plasma: PTAU217 and beta-amyloid 1-42. The proportion of these proteins tends to correlate with the occurrence or absence of amyloid plaques in the brain, which are among the characteristics of Alzheimer’s disease. The test does not measure the amyloid directly, but can signal its presence.
However, there is not yet a single definitive test to diagnose Alzheimer’s disease. Doctors depend mainly on various tools to diagnose the condition, which may include medical history, neurological examinations, cognitive and functional evaluations, cerebral image exams, cerebrospinal fluid analysis and, more recently, blood tests.
The FDA said that the results of the newly approved blood test should be evaluated in conjunction with other clinical information of the patient.
“Alzheimer’s disease affects many people, more than breast cancer and combined prostate cancer,” FDA commissioner Martin Makary said in Friday’s announcement. “Knowing that 10% of people 65 or older have Alzheimer’s, and that by 2050 this number should double, I hope that new medical products like this will help patients.”
According to the FDA, the new blood test – developed by the Fujirebio Biotechnology company Diagnostics Inc., based in Pennsylvania – can help increase access to detection of Alzheimer’s disease and reduce dependence on positron emission or pet exams, a type of image that can reveal amyloid plaques in the brain, but may be expensive, costing thousands of dollars without insurance.
The FDA said it has revised clinical trial data from the new blood test, involving plasma samples collected from 499 adults with cognitive impairment. The samples were evaluated using the blood test, and the results were compared with the results of the patients’ PET tomography or separate tests using cerebrospinal fluid samples, such as lumbar punctures.
The data showed that 91.7% of adults with positive results using the blood test had the presence of amyloid plates confirmed by their pet exam or cerebrospinal fluid test, and 97.3% of people with negative results had a negative result in the pet of amyloid or cephalorean liquid test, according to FDA.
The agency added that the risks associated with blood test are mainly the risk of a false positive or false negative result.
A “new era” in the research on Alzheimer’s
Preventive neurologist Richard Isaacson, who has established one of the first Alzheimer’s prevention clinics in the United States, said he has been using this blood test for years for research and applauded FDA permission. “It can provide more clarity about whether a person with memory loss can have Alzheimer’s disease. They can do this test as a screening test,” said Isaacson, research director at the Institute of Neurodegenerative Diseases in Florida.
Compared to costly pet tests or lumbar punctures, “this is a much simpler screening test with reasonable accuracy to inform the doctor that a person with cognitive decline has symptoms that are actually due to Alzheimer’s disease.”
But Isaacson warned that while FDA permission is “an important step” for the area, more research is needed to help inform how the results of blood tests should be interpreted and used to make clinical decisions.
“I think the next step as a field is to advance in education about what these tests mean and what they do not mean and for whom they should be used,” he said. “Because they mean different things in different people, depending on their risk factors and whether or not they have symptoms. So we are still at first.”
Fujirebio Diagnostics designed blood test to help detect Alzheimer’s disease early, when interventions are more effective, said President and CEO Monte Wiltse in a press release last year when the company registered its FDA test.
“An early and early diagnosis will also facilitate the development of new drug therapies, which are urgently necessary as the prevalence of DA increases with the rapid aging of the population globally,” Wiltse said.
It is estimated that over 5 people over 55 in the United States-about 42%-will develop dementia in their later years. However, in some cases amyloid deposits may begin to accumulate in the brain decades before the onset of Alzheimer’s symptoms. Early detection of these amyloid plaques could make way for a person to take action to slow disease progression, such as starting preventive drug treatment.
“For a long time the Americans have fought to get a simple and accurate diagnosis. With today’s action of FDA, we are hopeful that it will be easier for more individuals to receive a precise diagnosis earlier,” said Dr. Maria Carrillo, scientific director and leader of medical affairs at the Alzheimer Association, in a statement on Friday (16).
There are several tests developed in the market laboratory that can be used to detect blood biomarkers associated with Alzheimer’s, according to the Alzheimer’s Association, as well as experimental tests. But the Fujirebio Diagnostics test is the first to be approved by the FDA.
“Blood biomarkers are remodeling the way we identify and understand Alzheimer’s disease,” said Carrillo. “At the same time, there are important questions for health professionals to consider; in particular, who should be tested and when.”
For now, FDA approval “marks an important milestone,” said Dr. Howard Fillit, co -founder and scientific director of the drug discovery foundation for Alzheimer’s.
“The ability to diagnose Alzheimer’s earlier with a simple blood test, as we do for cholesterol, is a water divider, allowing more patients to receive treatment options that have the potential to slow down significantly or even prevent the disease,” Fillit said in an email on Friday. “This is a clear example of the new era of Alzheimer’s research, where innovation, science and technology come together to develop more affordable, economical and scalable tools that will pave the way for additional regulatory approvals of diagnostic tools.”
This content was originally published in FDA approve 1st blood test for early Alzheimer’s detection in the US on CNN Brazil.
Source: CNN Brasil
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