Clinical validation of Guardant360 CDx as a blood-based companion diagnostic for sotorasib.

ABSTRACT:

Objectives

Effective therapy for non-small-cell lung cancer (NSCLC) depends on morphological and genomic classification, with comprehensive screening for guideline-recommended biomarkers critical to guide treatment. Companion diagnostics, which provide robust genotyping results, represent an important component of personalized oncology. We evaluated the clinical validity of Guardant360 CDx as a companion diagnostic for sotorasib for detection of KRAS p.G12C, an important oncogenic NSCLC driver mutation.

Materials and methods

KRAS p.G12C was tested in NSCLC patients from CodeBreaK100 (NCT03600833) in pretreatment plasma samples using Guardant360 CDx liquid biopsy and archival tissue samples using therascreen® KRAS RGQ polymerase chain reaction (PCR) kit tissue testing. Matche

SUBMITTER: Bauml JM 

PROVIDER: S-EPMC10325630 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature