FDA Approves Roche’s Alzheimer’s Disease Blood Test For Use In Primary Care

Roche announced that the United States Food and Drug Administration (FDA) has cleared its Elecsys pTau181 test, a blood-based biomarker (BBM) test used in the initial assessment for Alzheimer’s disease and other causes of cognitive decline, for use in primary care settings. The Elecsys pTau181 test is intended for consumers 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.

Developed in collaboration with Eli Lilly and Company, the blood test . . .