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FDA Approves Pioneering Blood Test for Alzheimer's Detection

10/14/2025

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Summary

Story summary

The U.S. Food and Drug Administration approved the Elecsys pTau181 blood test, developed by Roche Diagnostics and Eli Lilly, to assess Alzheimer's in adults 55 and older with cognitive decline.
The test measures pTau181, a protein linked to Alzheimer's, with a 97.9% negative predictive value.
Experts caution about false positives and advise using this test with other assessments.
The approval follows Fujirebio's Lumipulse clearance, highlighting blood tests' role in Alzheimer's diagnostics.

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Story summary

The U.S. Food and Drug Administration approved the Elecsys pTau181 blood test, developed by Roche Diagnostics and Eli Lilly, to assess Alzheimer's in adults 55 and older with cognitive decline.
The test measures pTau181, a protein linked to Alzheimer's, with a 97.9% negative predictive value.
Experts caution about false positives and advise using this test with other assessments.
The approval follows Fujirebio's Lumipulse clearance, highlighting blood tests' role in Alzheimer's diagnostics.