Story perspectives

FDA Clears Roche, Eli Lilly’s Elecsys pTau217 Alzheimer’s Blood Test

8/25/2026

Summary

FDA Clears Test

U.S. FDA cleared Roche and Eli Lilly’s Elecsys pTau217 blood test for Alzheimer’s assessment in adults 55 and older.
The assay measures phosphorylated Tau 217 protein, a biomarker linked to amyloid plaque buildup.
Results are reported as positive, intermediate, or negative to help clinicians rule-in or rule-out disease.
Labcorp and Quest Diagnostics will offer the assay through their networks, using over 4,500 U.S. Roche analysers.

Summary

Isaacson Warns

Dr. Richard Isaacson warns the test’s positive predictive value is limited, raising false-positive concerns.
Isaacson says kidney disease or viral infections can skew pTau217 results, complicating interpretation.
Roche states the assay’s safety and effectiveness have not been proven for predicting dementia progression or monitoring therapies.
Jared R. Brosch says broader blood-biomarker use could boost diagnostic confidence and help families make timely care decisions.

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FDA Clears Test

U.S. FDA cleared Roche and Eli Lilly’s Elecsys pTau217 blood test for Alzheimer’s assessment in adults 55 and older.
The assay measures phosphorylated Tau 217 protein, a biomarker linked to amyloid plaque buildup.
Results are reported as positive, intermediate, or negative to help clinicians rule-in or rule-out disease.
Labcorp and Quest Diagnostics will offer the assay through their networks, using over 4,500 U.S. Roche analysers.

1 / 2