FDA clears Roche Lilly Alzheimer's blood test

The U.S. United States — Food and Drug Administration (FDA) cleared the Elecsys pTau217 blood test, developed by Roche in collaboration with Eli Lilly and Company, to help identify signs of Alzheimer's disease in people aged 55 and older with cognitive decline. The test detects phosphorylated tau-217 protein, a biomarker linked to amyloid plaque buildup, and provides positive, intermediate, and negative results to support rule-in and rule-out assessment of amyloid pathology. It is the first FDA-cleared single-biomarker blood test supporting both rule-in and rule-out across primary and specialty care settings. The clearance follows European approval in May and expands access to Alzheimer's diagnostics, as the test can run on over 4,500 Roche analyzers already installed in the U.S. Labcorp and C2N Diagnostics plan to offer the test through their laboratory networks, potentially broadening availability. The FDA clearance comes amid a race among drugmakers and diagnostic companies to develop simpler Alzheimer's tests, with Fujirebio's Lumipulse being the first FDA-cleared blood test for Alzheimer's assessment in 2025. Roche noted the test is not intended as a standalone diagnostic and should be interpreted with other clinical information.