Analytical validation and sequencing coverage studies suggest that performance of a liquid biopsy assay is tumor agnostic (DNA-is-DNA).

Analytical validation and sequencing coverage studies suggest that performance of a liquid biopsy assay is tumor agnostic (DNA-is-DNA).

Per regulatory and standard requirements (e.g., Clinical & Laboratory Standards Institute (CLSI) guidelines, United States Food and Drug Administration (FDA) correspondence), analytical validation (AV) for each companion diagnostic (CDx) biomarker should be repeated using a clinical sample set f...

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Main Authors: Wei Meng, Russell Petry, Norberto Pantoja Galicia, Allison van den Hout, Jessie Yu, Siliang Gong, Dhara Shah, Daokun Sun, Cui Guo, Shannon Bailey, Daniela Munafo, Ryan Woodhouse, Elizabeth Mansfield, Varun Pattani, Steven Perrault, Jun Zhou, Christine Vietz, Meijuan Li, Richard S P Huang
Format: Article
Language:English
Published: Public Library of Science (PLoS) 2025-01-01
Series:PLoS ONE
Online Access:https://doi.org/10.1371/journal.pone.0329392
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