Epidermal Growth Factor Receptor (EGFR) Amplification May Lead to Invalid Cobas EGFR Mutation Test v2 Results.

ABSTRACT: Background/Objectives: The cobas EGFR test v2, used for detecting EGFR mutations, can yield invalid results due to internal control (IC) issues, such as "IC not detected", "IC out of range: high Ct value", or "IC out of range: low Ct value". This study aimed to examine the incidence of invalid cobas results and explored the mechanism behind low IC Ct values. Methods: We retrospectively reviewed invalid cases, linking undetectable or high IC Ct values to inadequate DNA from small biopsies, as determined by conducting a pathological review. Cases with low IC Ct values were further tested, with the hypothesis of EGFR amplification confirmed using Sanger sequencing, the Idylla assay, next-generation sequencing (NGS), and fluorescence in situ hybridization (FISH). Results:

SUBMITTER: Hsieh MS 

PROVIDER: S-EPMC12025441 | biostudies-literature | 2025 Apr

REPOSITORIES: biostudies-literature