Recommendations related to the analytical equivalence assessment of gene panel testing.

ABSTRACT: Advances in cancer genome care over the past few years have included the development of gene panel testing for various biomarkers. This article summarizes issues and provides recommendations related to analytical performance evaluations for new oncology gene panels. The scope of these recommendations includes comprehensive genomic profiling assays related to gene panel testing that uses histological or serum specimens to detect gene mutations. As a research project of the Japan Agency for Medical Research and Development Research on Regulatory Science of Pharmaceuticals and Medical Devices, we convened the working group committee that consisted of more than 30 experts from academia, industry, and government. We have discussed the points that should be considered to allow maximal simplifica

SUBMITTER: Nagai S 

PROVIDER: S-EPMC9530854 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature