Washington, DC (May 19, 2025) – UsAgainstAlzheimer’s celebrates a major milestone with the U.S. Food and Drug Administration (FDA) clearance of the Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, the first-ever clearance of a blood test to aid in diagnosing Alzheimer’s disease. This major advancement provides a less invasive, faster, and more accessible way to detect the disease, offering hope to the millions of people affected by Alzheimer’s.

“For patients across the nation, this clearance removes a hurdle to bringing the test into everyday medical care,” said George Vradenburg, Chairman and Co-Founder of UsAgainstAlzheimer’s.  “In our surveys, about 25% of U.S. physicians reported that lack of FDA clearance was a barrier to them prescribing a blood test. Now, with a simple blood test that’s fully cleared by the FDA, patients can get answers faster, with fewer barriers, and at a fraction of the cost. This is a game-changer for patients, caregivers, and the millions of families affected by Alzheimer’s.”

One of the hallmarks of Alzheimer’s disease is the buildup of amyloid plaques in the brain, which can now be detected using the new blood test. The test works by measuring two proteins in the blood—pTau217 and β-amyloid 1-42—that are linked to the presence of these plaques. 

UsAgainstAlzheimer’s is committed to ensuring that blood tests, digital tools, and other diagnostic advancements become standard practice to improve lives and transform care for those living with Alzheimer’s.