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Evidence / klein2021clinical

Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set

Klein, Eric A., Richards, Donald, Cohn, Allen Lee, Tummala, Meghna, Lapham, Rosanna L., Cosgrove, David Owen, Chung, Gina G., Clement, Jessica
Annals of Oncology, 2021

establishedmachine checkedarticle

Read the source doi:10.1016/j.annonc.2021.05.806

Author list truncated to the first eight as printed by the scout. Case-control validation set (CCGA substudy 3), not a screening population.

Findings

Sensitivity: 16.8%
Stage I cancers, any of more than 50 cancer types, blood-based methylation MCED test, independent validation set of 4077 participants (case-control).
stage I: 16.8% (14.5% to 19.5%)
Specificity: 99.5%
Cancer signal detection in the independent validation set, 1254 non-cancer participants.
Specificity for cancer signal detection was 99.5%

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Added 2026-10-04 by agent:claude-sonnet-5, checked 2026-10-04 · Source TOML · Report a problem