# Oncomine Dx Target Test

Source: https://onco.cc/drugs/oncomine-dx-target-test/  
OnCo record `oncomine-dx-target-test` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-10
- Tags: test
- 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: US 2017: Companion diagnostic for BRAF, ROS1 and EGFR-directed therapies in NSCLC; Japan 2019: Multi-gene companion diagnostic system for NSCLC; US 2020: RET fusion companion claim (pralsetinib); US 2021: IDH1 companion claim in cholangiocarcinoma (ivosidenib)

## 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.

## Sources

- FDA PMA P160045: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?id=P160045
- Thermo Fisher: Oncomine Dx Target Test: https://www.thermofisher.com/uk/en/home/clinical/diagnostic-testing/condition-disease-diagnostics/oncology-diagnostics/oncomine-dx-target-test.html

## Connected records

- cancers: [Biliary tract cancer (cholangiocarcinoma)](https://onco.cc/cancers/cholangiocarcinoma/), [Non-small-cell lung cancer](https://onco.cc/cancers/nsclc/)
- technologies: [Companion diagnostics](https://onco.cc/technologies/companion-diagnostic/), [Comprehensive genomic profiling](https://onco.cc/technologies/cgp/)
- targets: [BRAF](https://onco.cc/targets/braf/), [EGFR](https://onco.cc/targets/egfr/), [IDH1 / IDH2](https://onco.cc/targets/idh/), [RET](https://onco.cc/targets/ret/), [ROS1](https://onco.cc/targets/ros1/)
- drugs: [Ivosidenib](https://onco.cc/drugs/ivosidenib/), [Pralsetinib](https://onco.cc/drugs/pralsetinib/)
- companies: [Thermo Fisher Scientific](https://onco.cc/companies/thermo-fisher/)
- terms: [Companion diagnostic](https://onco.cc/terms/companion-diagnostic-term/), [Next-generation sequencing (NGS)](https://onco.cc/terms/ngs/)
- biomarkers: [EGFR exon 19 deletion](https://onco.cc/biomarkers/egfr-exon-19-deletion/), [EGFR exon 20 insertion](https://onco.cc/biomarkers/egfr-exon-20-insertion/), [HER2 (ERBB2) activating mutation](https://onco.cc/biomarkers/her2-mutation/), [IDH1 R132 mutation](https://onco.cc/biomarkers/idh1-r132/), [RET fusion and RET mutation](https://onco.cc/biomarkers/ret-fusion/), [ROS1 fusion (ROS1-positive)](https://onco.cc/biomarkers/ros1-fusion/)

---
JSON: https://onco.cc/api/v1/entities/oncomine-dx-target-test.json