FDA Approves Roche and Eli Lilly Blood Test for Alzheimer’s Risk Detection
The FDA has authorized a new plasma test from Roche and Eli Lilly that gauges the likelihood of amyloid pathology in adults over 55.
The U.S. Food and Drug Administration has given clearance to Roche and Eli Lilly’s Elecsys Phospho-Tau (217P) plasma test, a blood-based assay aimed at detecting the probability of amyloid pathology in individuals older than 55. This biomarker focuses on tau protein phosphorylation, a hallmark linked to Alzheimer’s disease, and is designed to be less invasive and costly than current PET imaging or cerebrospinal-fluid methods.
The companies emphasize that the test can be run using existing laboratory equipment, simplifying adoption across diagnostic labs. It is positioned as a supplemental tool rather than a definitive diagnostic, requiring interpretation alongside other clinical information. Major testing providers Labcorp and Quest Diagnostics have announced intentions to roll out the assay, expanding access for physicians and patients. The approval marks a step toward broader, more affordable screening for early Alzheimer’s risk.
Why it matters
A cheaper, less invasive blood test could broaden early detection of Alzheimer’s risk for older adults.
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