The FDA has authorized the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first blood test cleared in the U.S. to help diagnose Alzheimer’s disease. Targeted at adults 55 and older with symptoms of cognitive decline, this simple blood draw can indicate amyloid plaques linked to Alzheimer’s, reducing reliance on costly and invasive PET scans or spinal taps. In clinical trials, the test demonstrated over 91% accuracy in identifying amyloid buildup. Officials emphasize that, while not a stand-alone diagnostic, this advancement marks an important step toward earlier, more accessible Alzheimer’s detection for millions of Americans. The FDA issued clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio to Fujirebio Diagnostics, Inc.
“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.”
This blood test measures specific protein levels in plasma, helping doctors detect amyloid plaques in the brain—an indicator of Alzheimer’s. Unlike traditional PET scans, which are both expensive and expose patients to radiation, the Lumipulse test is far less invasive and only requires a simple blood draw. Experts believe this development could significantly improve early detection for patients, potentially accelerating interventions and research into effective treatments for the progressive disease.
Alzheimer’s disease continues to challenge both patients and the medical community with its slow but relentless progression. Doctors often look for amyloid plaques in the brain—a key characteristic of the disease—to help with diagnosis. These plaques can be identified using amyloid PET scans, which allow physicians to potentially spot Alzheimer’s years before symptoms appear. However, PET scans remain expensive, take considerable time, and involve some radiation exposure. Despite these barriers, early detection remains crucial, as it could lead to better planning and, in the future, possibly more effective interventions for those at risk.
“Nearly 7 million Americans are living with Alzheimer’s disease and this number is projected to rise to nearly 13 million,” said Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D. “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.”
