Thermo Fisher's NGS Assay Receives FDA Approval as a Companion Diagnostic for ZEGFROVY and for Tumor Profiling

  • CARLSBAD, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the U.S. Food and Drug Administration (FDA) has approved the Oncomine\u2122 Dx Express Test on the Ion Torrent\u2122 Genexus\u2122 Dx Integrated Sequencer as an in vitro diagnostic (IVD) assay for use as a companion diagnostic (CDx) for Dizal's ZEGFROVY\u00ae (sunvozertinib) and in tumor profiling. This approval brings rapid next-generation sequencing (NGS) to decentralized clinical settings closer to.