A breakthrough blood test designed by Roche has received FDA Breakthrough Device Designation for its potential to identify Alzheimer’s disease earlier. Developed in collaboration with Eli Lilly, the test, branded “Elecsys,” can detect elevated levels of the pTau217 protein in human blood plasma, indicating early stages of Alzheimer’s. Laura Parnas, from Roche Diagnostics North America, highlighted the test’s potential to provide timely and cost-effective Alzheimer’s diagnosis on a global scale. With FDA approval, Roche aims to make the test available for clinical use promptly, expanding its partnerships and receiving expert feedback for device development.
Both Roche and Eli Lilly are optimistic about the collaboration’s ability to enhance testing and diagnosis for Alzheimer’s. Parnas emphasized the significance of blood testing in advancing neuropathology and improving access to accurate diagnoses for the rapidly growing number of individuals affected by dementia. This new blood test could be a crucial tool in monitoring the effectiveness of emerging disease-modifying treatments for neurological diseases.
