The U.S. Food and Drug Administration (FDA) cleared the first-ever blood test to test for Alzheimer's disease.
In a press release Friday, the agency announced approval of the first Vitro diagnostic device, Lumipulse.
This method is suitable for early detection of Alzheimer's disease in adult patients over 55 years of age who show signs and symptoms of the disease.
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The new technology detects amyloid plaques in the brain, a distinct sign of Alzheimer's disease.
The U.S. Food and Drug Administration cleared the first-ever blood test to test for Alzheimer's disease. (iStock)
Although PET scans can pick up these plaques, they can be "expensive and time-consuming" while exposing patients to radiation, according to the FDA.
The agency said the new Lumipulse device reduces the need for PET scanning or other invasive testing.
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In a clinical study of 499 plasma samples with impaired cognition in adults, the Lumipulse test detected amyloid plaques in 91.7% of individuals.
The results show that the new blood tests can “reliably predict or not the presence of amyloid pathology associated with Alzheimer’s disease in patients with cognitive impairment,” the FDA concluded.
According to the FDA, the new technology works by detecting amyloid plaques in the brain, which is a sign of Alzheimer's disease. (iStock)
The FDA points out the risk of Lumipulse producing false positive tests, which can lead to inappropriate diagnosis and unnecessary treatment.
"Alzheimer's disease affects too many people, more than breast and prostate cancer combined," MPH's FDA specialist Marty Makary wrote in a statement.
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"Knowing that 10% of people aged 65 and older have Alzheimer's, that number is expected to double by 2050, and I hope new medical products like this can help patients," he said.
One expert commented: “Today’s clearance is an important step in the diagnosis of Alzheimer’s disease, making it easier and possibly more accessible to patients with the disease.” (iStock)
Michelle Tarver, director of equipment center and radiation health, also commented in a press release that nearly 7 million Americans live with Alzheimer's.
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"This number is expected to increase to nearly 13 million," she said.
“Today’s clearance is an important step in the diagnosis of Alzheimer’s disease, making it easier and possibly more accessible to patients with the disease.”