FDA approves first-ever blood test for Alzheimer’s detection

The first-ever blood test to detect Alzheimer’s disease has been cleared by the U.S. Food and Drug Administration (FDA).

In a Friday press release, the agency announced its approval of the first in-vitro diagnostic device, Lumipulse.

The method is intended for early Alzheimer’s detection in adult patients over the age of 55 who are exhibiting signs and symptoms of the disease.

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The new technology works by detecting amyloid plaques in the brain, a telltale sign of Alzheimer’s.

While PET scans can pick up these plaques, they can be “costly and time-consuming” while exposing patients to radiation, according to the FDA.

The new Lumipulse device reduces the need for a PET scan or other invasive testing, the agency said.

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In a clinical study of 499 plasma samples from cognitively impaired adults, 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 who are cognitively impaired,” the FDA concluded.

The FDA noted the risk of false positive test results from Lumipulse, which could lead to inappropriate diagnosis and unnecessary treatment.

FDA Commissioner Marty Makary, M.D., MPH, wrote in a statement, “Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined.”

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“Knowing that 10% of people aged 65 and older have Alzheimer’s, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients,” he said.

Center for Devices and Radiological Health Director Michelle Tarver, M.D., PhD, also commented in the press release that nearly seven million Americans are living with Alzheimer’s.

“And this number is projected to rise to nearly 13 million,” she said. 

“Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”