The U.S. Food and Drug Administration has authorized Roche and Eli Lilly's Elecsys Phospho-Tau Plasma blood test for the detection of Alzheimer's-associated amyloid pathology in individuals aged 55 and older.
The test provides three result categories—positive, intermediate, and negative—to assist clinicians in assessing the likelihood of amyloid pathology, with results to be interpreted alongside clinical data and other diagnostic findings. The agency noted the test is intended to address an existing diagnostic gap, as an estimated 75% of individuals living with dementia have not previously undergone Alzheimer's evaluation.
Major U.S. lab services providers Quest Diagnostics and Labcorp confirmed plans to integrate the test into their offerings. Labcorp described the test as a critical tool for physicians to confirm or exclude amyloid pathology in patients displaying signs of cognitive decline, while Quest will market the test under the AD-Detect brand as part of its portfolio of blood-based Alzheimer's biomarker assays.
The FDA's clearance follows growing recognition of the need for scalable, non-invasive diagnostic tools to improve early detection of Alzheimer's disease amid rising global dementia prevalence.
