New Alzheimer's Test Approved by FDA—What to Know
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The U.S. Food and Drug Administration (FDA) has cleared marketing for a new blood test to diagnose Alzheimer's disease in people who are already exhibiting symptoms.
This new test is the first blood test ever approved for diagnostics of the disease, according to a press release issued Friday by the FDA.
People suffering from the Alzheimer's suffer from memory loss that eventually erases their ability to complete everyday tasks.
"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," FDA Commissioner Martin A. Makary said in the press release.
Newsweek reached out to Makary for further comment via email Saturday during non-working hours.
Why It Matters
Alzheimer's affects an estimated 7.2 million people in the U.S. age 65 and over, with 74 percent of those patients aged 75 or older, according to the Alzheimer's Association 2025 Disease Facts and Figures report.
The new test is set to create more accessible diagnostic results and decrease the reliance on more invasive testing such as Positron Emission Tomography (PET) scans.
Early detection can lead to better, more effective treatment that delays more intense symptoms of the disease.
This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer's affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques.
This illustration made available by the National Institute on Aging/National Institutes of Health depicts cells in an Alzheimer's affected brain, with abnormal levels of the beta-amyloid protein clumping together to form plaques.
National Institute on Aging, NIH via AP
What To Know
While the disease has a higher percentage in older age groups, researchers believe about 110 people out of 100,000, aged 30 to 64 years, could be suffering from the disease. An estimated 1 in 9 people over the age of 65 are believed to suffer from Alzheimer's dementia.
The new test, known as the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, detects amyloid plaques through blood testing, a type of protein indicative of Alzheimer's, the Alzheimer's Association explained in a Friday press release.
These plaques can be seen in patients through a PET scan, according to the FDA.
The Mayo Clinic discovered a way to prevent the accumulation of such proteins nearly a decade ago, meaning they can be identified and treated more quickly with the latest device.
This device is not the first to be used in clinical trials, but it is the first to receive FDA clearance for marketing.
While the test is not supposed to be all inclusive, it should help medical professionals in part of their wider diagnostic practices for treating Alzheimer's, the FDA's press release said.
What People Are Saying
Director Michelle Tarver of the Center for Devices and Radiological Health said in the FDA press release: "Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million. 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."
FDA Commissioner Martin A. Makary said in the FDA press release: "Alzheimer's disease impacts too many people, more than breast cancer and prostate cancer combined. 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."
Maria C. Carrillo, Alzheimer's Association chief science officer, said in a press release: "Today marks another important step in Alzheimer's disease diagnosis. For too long Americans have struggled to get a simple and accurate diagnosis; with today's action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier."
She added: "This interest in early diagnosis and treatment highlights how important it is that we keep advancing toward diagnostic testing that is simple to administer and widely available."
What Happens Next?
Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio still has a few hurdles before it is widely approved and available for diagnostic use.
While clearance for this device is currently only for marketing, it was given a breakthrough device designation, meaning the development of the product is expedited because of its ability to help diagnosis damaging health conditions.
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