Posted by Michael Wonder on 15 Oct 2025
Roche's Elecsys pTau181 becomes the only FDA cleared blood test for use in primary care to rule out Alzheimer's related amyloid pathology
13 October 2025 - Roche today announced that the US FDA has cleared its Elecsys pTau181 test, the only blood based biomarker test indicated as an aid in the initial assessment for Alzheimer's disease and other causes of cognitive decline in the primary-care setting.
The Elecsys pTau181 test is intended for patients ages 55 and older presenting with signs, symptoms or complaints of cognitive decline. It measures phosphorylated Tau (pTau) 181 protein in human plasma, a key biomarker for Alzheimer's pathology, including amyloid plaque and tau aggregate pathology.
