What Factors Should Be Considered In The Coverage Of Gene Mutation Sites For CDx？

For the gene mutation detection reagent of tumor companion diagnosis (CDx), if the gene is known to have multiple mutation sites for the same companion diagnosis purpose (such as the same companion drug), the coverage of mutation sites shall be fully considered in combination with product risk benefit analysis in subsequent product design, and the detection range of sites shall not be arbitrarily reduced for the convenience of product evaluation. For example, when KRAS gene mutation is used for tumor companion diagnosis, because it is a negative companion diagnostic gene detection and related to adverse drug reactions, insufficient coverage of mutation sites may increase the risk of patients.