{"entity":{"id":"oncomine-dx-express","kind":"drug","name":"Oncomine Dx Express Test","aka":[],"tldr":"Thermo Fisher's newer sequencing test for lung cancer, companion to sunvozertinib for EGFR exon 20 insertions and to sevabertinib for HER2 mutations.","summary":"Life Technologies' (Thermo Fisher Scientific) Oncomine Dx Express Test was approved on 2 July 2025 (PMA P240040) as the companion diagnostic for sunvozertinib in non-small-cell lung cancer with EGFR exon 20 insertions. A supplement on 9 September 2026 added sevabertinib for HER2 (ERBB2) activating mutations: single-nucleotide variants in exons 18 to 21 of the kinase domain and exon 20 insertions. It is a separate device from the older Oncomine Dx Target Test.","status":"approved","asOf":"2026-11-03","links":[{"label":"FDA PMA P240040","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P240040"},{"label":"FDA: List of cleared or approved companion diagnostic devices","url":"https://www.fda.gov/medical-devices/in-vitro-diagnostics/list-cleared-or-approved-companion-diagnostic-devices-in-vitro-and-imaging-tools"}],"tags":["test"],"related":["oncomine-dx-target-test","egfr-exon-20-insertion"],"cancers":["nsclc"],"sections":[],"technologies":["companion-diagnostic"],"targets":["egfr","her2"],"drugs":["sunvozertinib","sevabertinib"],"companies":["life-technologies"],"institutions":[],"pathways":[],"terms":["ngs","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Oncomine Dx Express Test","modality":"Tissue NGS companion diagnostic test","mechanism":"Next-generation sequencing of lung tumour tissue (FDA generic name: next generation sequencing oncology panel, somatic or germline variant detection system).","approvals":[{"region":"US","year":2025,"indication":"Companion diagnostic for sunvozertinib in NSCLC with EGFR exon 20 insertions"},{"region":"US","year":2026,"indication":"Companion diagnostic for sevabertinib in NSCLC with HER2 activating mutations"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/oncomine-dx-express/","neighbours":{"drug":[{"id":"oncomine-dx-target-test","kind":"drug","name":"Oncomine Dx Target Test","route":"/drugs/oncomine-dx-target-test/"},{"id":"sevabertinib","kind":"drug","name":"Sevabertinib","route":"/drugs/sevabertinib/"},{"id":"sunvozertinib","kind":"drug","name":"Sunvozertinib","route":"/drugs/sunvozertinib/"}],"biomarker":[{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"}],"cancer":[{"id":"nsclc","kind":"cancer","name":"Non-small-cell lung cancer","route":"/cancers/nsclc/"}],"technology":[{"id":"companion-diagnostic","kind":"technology","name":"Companion diagnostics","route":"/technologies/companion-diagnostic/"}],"target":[{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"her2","kind":"target","name":"HER2","route":"/targets/her2/"}],"company":[{"id":"life-technologies","kind":"company","name":"Life Technologies","route":"/companies/life-technologies/"}],"term":[{"id":"companion-diagnostic-term","kind":"term","name":"Companion diagnostic","route":"/terms/companion-diagnostic-term/"},{"id":"ngs","kind":"term","name":"Next-generation sequencing (NGS)","route":"/terms/ngs/"}]}}