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In a move that should help diagnose Alzheimer’s disease (AD) cheaper, earlier, and easier, the U.S. Food and Drug Administration (FDA) approved the first blood test to help identify AD in its early stages, potentially leading to more effective treatments.
AD’s hallmark is progressive memory loss and dementia. It is often not detected until patients present such symptoms, making slowing down disease progression more difficult than if treatment began earlier.
“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” Martin A. Makary, FDA director, said in a press release. “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.”
As the population ages, physicians expect cases of the disease to soar. So detecting it and treating it early could make a significant impact.
Not long ago, the only definitive physiological way to confirm that a patient had AD was to identify plaques and tangles in their brain after they died. Then, imaging in 2004 emerged — but the first technique to visualize those signposts of the disease in the brain required a cyclotron — a pricey machine that accelerated radioactive particles to high speeds before focusing them on the brain. Techniques employing PET imaging followed, using a variety of tracer elements.
Although effective, such tests are both expensive and cumbersome and probably not efficient enough to handle the growing need for early diagnosis. Cerebrospinal fluid tests were also developed, but extraction through spinal tap is painful.
The blood test was developed by Fujirebio Diagnostics, a global diagnostics company headquartered in Japan. The test’s name is called “The Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio.” It looks for proteins in the blood that are associated with amyloid plaques in the brain.
The company administered the test in 499 patients, correctly predicting AD in 92 percent of the patients with the disease and accurately ruling out 97 percent of the patients who didn’t have AD. The test results were confirmed with either PET scan diagnostics or analyzing cerebrospinal fluid.
The test, which requires a simple blood draw, is less invasive than performing a spinal tap to test cerebrospinal fluid and less expensive than PET scans. The hope is that more people showing early signs of AD will receive the blood test, and, if diagnosed, receive treatment to slow disease progression.
“The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment,” Monte Wiltse, president and CEO at Fujirebio Diagnostics, said in a press release. “The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective.”
The test will be offered to patients 55 and older that are showing some signs or symptoms of AD.
This article is not offering medical advice and should be used for informational purposes only.
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Before joining Discover Magazine, Paul Smaglik spent over 20 years as a science journalist, specializing in U.S. life science policy and global scientific career issues. He began his career in newspapers, but switched to scientific magazines. His work has appeared in publications including Science News, Science, Nature, and Scientific American.