Roche says FDA clears Elecsys pTau181 test

Roche (RHHBY) announced that the United States 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 181 protein in human plasma, a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.