The US Food and Drug Administration has approved a new blood test to assist in diagnosing Alzheimer’s disease. Produced by Roche, the test measures levels of a phosphorylated tau protein in the blood. This development aims to enable earlier screening and access to treatments like monoclonal antibodies.
Last month, the US Food and Drug Administration approved a new blood test designed to assist in the diagnosis of Alzheimer’s disease. The test, named Elecsys pTau181 and produced by Roche, measures the concentration of a specific molecule in the blood: a phosphorylated form of the tau protein.
Tau is one of two key proteins implicated in Alzheimer’s and certain types of dementia, the other being amyloid. These proteins become malformed and accumulate in the brains of affected patients. It is believed that this buildup interferes with the communication between brain cells, contributing to the symptoms observed in these patients.
New diagnostic kits like Elecsys pTau181 are intended to revolutionize early screening for the disease. By detecting these biomarkers sooner, the test could allow patients to receive treatments—such as monoclonal antibodies—earlier in the progression of Alzheimer’s. This approval marks a step toward more accessible and less invasive diagnostic methods compared to traditional brain imaging or spinal fluid tests.