Loading
The first FDA-approved gene panel that could match one biopsy to several different lung cancer drugs at once.
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.
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. Connects to EGFR, BRAF, ROS1, RET and IDH1 / IDH2.
1.Oncomine Dx Target Test slips into a pocket on EGFR.
| Region | Year | Indication |
|---|---|---|
| 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) |
Country and place are remembered in this browser only. A postcode is sent to OpenStreetMap's Nominatim service to find coordinates when you press the button; nothing else leaves your device.
Query for this drug: (TITLE:"Oncomine Dx Target Test" OR ABSTRACT:"Oncomine Dx Target Test") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Oncomine Dx Target Test, not a curated reading list.
Shares EGFR exon 20 insertion, HER2 (ERBB2) activating mutation, Companion diagnostic, EGFR exon 19 deletion and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Companion diagnostics, EGFR and the tag test.
Shares RET fusion and RET mutation, Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling and the tag test.
Shares Companion diagnostic, EGFR exon 19 deletion, Companion diagnostics, BRAF and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), EGFR, Comprehensive genomic profiling and the tag test.
Shares Companion diagnostics, Next-generation sequencing (NGS), Comprehensive genomic profiling, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Non-small-cell lung cancer and the tag test.
Shares Companion diagnostics, Non-small-cell lung cancer and the tag test.