FDA Approves Blood Test to Detect Alzheimer’s

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The Food and Drug Administration (FDA) has approved the first blood test to help doctors diagnose Alzheimer’s disease in people showing memory or thinking problems. Called the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, this test looks for signs of Alzheimer’s by measuring two specific proteins in the blood. These proteins are linked to the buildup of amyloid plaques in the brain — a key feature of Alzheimer’s.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “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.”

Until now, confirming Alzheimer’s, a condition that affects an approximately 1 in 9 people aged 65 years or older living in the U.S., often meant getting a PET scan (which is expensive and exposes patients to radiation) or a spinal tap (which can be invasive and uncomfortable). This new test requires only a simple blood draw, making it much easier and less stressful for patients.

In a clinical study, the test was accurate 91.7% of the time in predicting whether a person had signs of Alzheimer’s in their brain. It’s designed for people over 55 who are already showing symptoms and are being seen in specialized memory clinics.

“Nearly 7 million Americans are living with Alzheimer’s disease, and this number is projected to rise to nearly 13 million,” Michelle Tarver, M.D., Ph.D., director for the Center for Devices and Radiological Health (CDRH), said in a statement. “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.”

While there is no cure yet, treatments can help manage symptoms or slow disease progression. Current treatments include medications to improve memory or thinking, amyloid plaque-targeting drugs, therapies to support mood, sleep and behavior, and life style changes, such as exercise, staying socially active and eating a brain-healthy diet.

Organizations such as the Alzheimer’s Association offer support groups, caregiving tips and resources in English and Spanish. Patients and caregivers are also encouraged to talk to their healthcare provider about local services or clinical trials.