External quality assessment (EQA) for tumor mutational burden: results of an international IQN path feasibility pilot scheme.

ABSTRACT: Tumor mutational burden (TMB) has recently been approved as an agnostic biomarker for immune checkpoint inhibitors. However, methods for TMB testing have not yet been standardized. The International Quality Network for Pathology (IQNPath) organized a pilot external quality assessment (EQA) scheme for TMB testing. The aim of this program was the validation of the materials and the procedures for the EQA of this complex biomarker. Five formalin-fixed paraffin-embedded (FFPE) cell lines were selected to mimic the various TMB values observed in clinical practice. The FFPE samples were tested with the FoundationOne CDx (F1CDx) assay as the reference test and three commercially available targeted sequencing panels. Following this internal validation, the five cell lines were sent to 29 laborator

SUBMITTER: Esposito Abate R 

PROVIDER: S-EPMC9931778 | biostudies-literature | 2023 Feb

REPOSITORIES: biostudies-literature