The Alzheimer’s blood test developed through a collaboration between Roche and Lilly has been granted a breakthrough device designation by the U.S. Food and Drug Administration (FDA).
The test, Roche's Elecsys amyloid plasma assay, quantifies phosphorylated fragments of the brain protein tau, known as phosphorylated tau 217 (p-tau217), to identify a biomarker that can distinguish Alzheimer's from other neurodegenerative disorders, Roche said in a statement. The biomarker used has shown strong performance in studies, with the aim of diagnosing Alzheimer's earlier in its course.
The breakthrough device designation is intended to speed development and expedite FDA review.
Previously, Roche and Lilly announced their collaboration on the Elecsys Amyloid Plasma Panel, which measures p-tau181 protein and apolipoprotein E4 in human blood plasma. The panel was granted breakthrough device designation by the FDA in July 2022.
