{"entity":{"id":"oncomine-dx-target-test","kind":"drug","name":"Oncomine Dx Target Test","aka":[],"tldr":"The first FDA-approved gene panel that could match one biopsy to several different lung cancer drugs at once.","summary":"Approved 22 June 2017 (PMA P160045, Life Technologies, a Thermo Fisher business) as the first next-generation sequencing companion diagnostic covering multiple markers: BRAF V600E (dabrafenib plus trametinib), ROS1 fusions (crizotinib) and EGFR mutations (gefitinib) in non-small-cell lung cancer. Claims were later added for RET fusions (pralsetinib, 2020) and for IDH1 mutations in cholangiocarcinoma (ivosidenib, 2021). It was also approved in Japan (2019) as a companion diagnostic system reimbursed for lung cancer. Its short turnaround and modest tissue requirement made it a workhorse for in-hospital laboratories, in contrast to send-out tests such as FoundationOne CDx.","status":"approved","asOf":"2026-09-10","links":[{"label":"FDA PMA P160045","url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160045"},{"label":"Thermo Fisher: Oncomine Dx Target Test","url":"https://www.thermofisher.com/uk/en/home/clinical/diagnostic-testing/condition-disease-diagnostics/oncology-diagnostics/oncomine-dx-target-test.html"}],"tags":["test"],"related":[],"cancers":["nsclc","cholangiocarcinoma"],"sections":[],"technologies":["companion-diagnostic","cgp"],"targets":["egfr","braf","ros1","ret","idh"],"drugs":["pralsetinib","ivosidenib"],"companies":["thermo-fisher"],"institutions":[],"pathways":[],"terms":["ngs","companion-diagnostic-term"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":["What a result means: a reported driver alteration points to a specific approved pill; panels need enough tumour in the biopsy, and a failed sample is not a negative result."],"brand":"Oncomine Dx Target Test","modality":"Tissue NGS companion diagnostic test (multi-gene panel)","mechanism":"Amplicon-based DNA and RNA sequencing on the Ion Torrent platform, detecting variants in 23 genes from formalin-fixed tumour tissue in a few days, with companion claims for several lung and bile-duct cancer drugs.","approvals":[{"region":"US","year":2017,"indication":"Companion diagnostic for BRAF, ROS1 and EGFR-directed therapies in NSCLC"},{"region":"Japan","year":2019,"indication":"Multi-gene companion diagnostic system for NSCLC"},{"region":"US","year":2020,"indication":"RET fusion companion claim (pralsetinib)"},{"region":"US","year":2021,"indication":"IDH1 companion claim in cholangiocarcinoma (ivosidenib)"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/oncomine-dx-target-test/","neighbours":{"cancer":[{"id":"cholangiocarcinoma","kind":"cancer","name":"Biliary tract cancer (cholangiocarcinoma)","route":"/cancers/cholangiocarcinoma/"},{"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/"},{"id":"cgp","kind":"technology","name":"Comprehensive genomic profiling","route":"/technologies/cgp/"}],"target":[{"id":"braf","kind":"target","name":"BRAF","route":"/targets/braf/"},{"id":"egfr","kind":"target","name":"EGFR","route":"/targets/egfr/"},{"id":"idh","kind":"target","name":"IDH1 / IDH2","route":"/targets/idh/"},{"id":"ret","kind":"target","name":"RET","route":"/targets/ret/"},{"id":"ros1","kind":"target","name":"ROS1","route":"/targets/ros1/"}],"drug":[{"id":"ivosidenib","kind":"drug","name":"Ivosidenib","route":"/drugs/ivosidenib/"},{"id":"pralsetinib","kind":"drug","name":"Pralsetinib","route":"/drugs/pralsetinib/"}],"company":[{"id":"thermo-fisher","kind":"company","name":"Thermo Fisher Scientific","route":"/companies/thermo-fisher/"}],"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/"}],"biomarker":[{"id":"egfr-exon-19-deletion","kind":"biomarker","name":"EGFR exon 19 deletion","route":"/biomarkers/egfr-exon-19-deletion/"},{"id":"egfr-exon-20-insertion","kind":"biomarker","name":"EGFR exon 20 insertion","route":"/biomarkers/egfr-exon-20-insertion/"},{"id":"her2-mutation","kind":"biomarker","name":"HER2 (ERBB2) activating mutation","route":"/biomarkers/her2-mutation/"},{"id":"idh1-r132","kind":"biomarker","name":"IDH1 R132 mutation","route":"/biomarkers/idh1-r132/"},{"id":"ret-fusion","kind":"biomarker","name":"RET fusion and RET mutation","route":"/biomarkers/ret-fusion/"},{"id":"ros1-fusion","kind":"biomarker","name":"ROS1 fusion (ROS1-positive)","route":"/biomarkers/ros1-fusion/"}]}}