By Fineline Cube 
US-based Thermo Fisher Scientific Inc. (NYSE: TMO) announced that it has received marketing approval from the US Food and Drug Administration (FDA) for its Oncomine Dx Express Test on the Ion Torrent Genexus Dx Integrated Sequencer. The test is authorized as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for China-based Dizal Pharmaceutical Co., Ltd’s (SHA: 688192) Zegfrovy (sunvozertinib) and in tumor profiling.
Companion Diagnostic Utility
The Oncomine Dx Express Test provides a rapid and reliable method for identifying patients with non-small cell lung cancer (NSCLC) who harbor EGFR exon 20 insertion mutations. This approval facilitates earlier intervention and expands access to targeted treatment for patients eligible for Zegfrovy.
Zegfrovy Background
Zegfrovy (sunvozertinib) is an oral, irreversible, and highly selective EGFR tyrosine kinase inhibitor (TKI) targeting multiple EGFR mutation subtypes. It was approved in China under priority review in August 2023 and received accelerated approval in the US earlier this week for the treatment of NSCLC patients with EGFR exon 20 insertion mutations.-Fineline Info & Tech