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

ABSTRACT: 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 for each cancer type listed as an indication in labelling for a CDx. Using data from AV studies and Foundation Medicine (FMI)'s clinical database, we evaluated the hypothesis that analytical performance of the FoundationOne®Liquid CDx (F1LCDx) assay is not impacted by cancer type and that large sets of clinical, tumor-specific samples might not be necessary for analytical validation of specific CDx biomarkers. We retrospectively evaluated all liquid biopsy samples from F1LCDx assay AV studies that we

SUBMITTER: Meng W 

PROVIDER: S-EPMC12316276 | biostudies-literature | 2025

REPOSITORIES: biostudies-literature