September 2025—The FDA has approved Thermo Fisher Scientific’s Oncomine Dx Express test, an in vitro diagnostic assay, for use as a companion diagnostic for Dizal’s Zegfrovy (sunvozertinib) to identify patients with non-small cell lung cancer harboring EGFR exon 20 insertion mutations. In addition, the test has been approved for tumor profiling in solid tumors and detects cancer mutations with evidence of clinical significance and potential clinical significance across 46 genes.
The Oncomine Dx Express test on the Ion Torrent Genexus Dx generates results in as few as 24 hours.
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