FDA Approves New Blood Test to Help Rule Out Alzheimer’s Disease

The U.S. Food and Drug Administration (FDA) has approved a new blood test designed to help primary care physicians identify whether cognitive symptoms in older adults are likely due to Alzheimer’s disease.

The test, called Elecsys pTau181, is intended for patients aged 55 and older with symptoms of cognitive decline. According to CNN, the test measures levels of phosphorylated tau protein (pTau181)—a biological marker linked to Alzheimer’s disease.

While the test does not diagnose Alzheimer’s on its own, it can help doctors rule out the disease in some patients and determine who may benefit from further neurological testing or brain imaging.

Medical experts say the test could be a game-changer for earlier and more accessible detection, especially in areas with limited access to specialists or advanced diagnostic imaging, such as PET scans.

If results are positive, patients are advised to undergo additional evaluation, as Alzheimer’s cannot be confirmed with a blood test alone.

The Elecsys pTau181 test is now one of a growing number of blood-based diagnostic tools gaining approval in the fight against Alzheimer’s disease, offering hope for earlier intervention and better care planning.