FDA clears Alzheimer's blood test to flag brain changes earlier
TL;DR Summary
The FDA has cleared Roche and Eli Lilly’s Elecsys pTau217 blood test to help identify Alzheimer’s disease–related brain changes in people 55 and older with cognitive decline; the biomarker test can run on more than 4,500 Roche analyzers in the United States and is intended to aid, not replace, diagnosis when used with other clinical information. European approval followed in May, and Labcorp and Quest Diagnostics plan to offer the test nationally, potentially broadening access as developers push for earlier detection and treatment. Experts warn that a positive pTau217 result is not a definitive diagnosis and must be interpreted alongside other data.
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