FDA Clears Roche Alzheimer’s Test

FDA has cleared Roche’s Elecsys pTau 181 test, which the company says is 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. Roche says the Elecsys pTau 181 test is intended for patients aged 55 and older presenting with signs, symptoms, or complaints of cognitive decline.

The test reportedly measures phosphorylated Tau (pTau) 181 protein in human plasma, said to be a key biomarker for Alzheimer’s pathology, including amyloid plaque and tau aggregate pathology.

The company statement says that in a non-interventional clinical study in 312 participants, the results showed that in an early disease stage, low-prevalence population reflective of a primary care setting, Elecsys pTau 181 could rule out Alzheimer’s pathology with a 97.9% negative predictive value.