Oncomine Dx Target Test
The first FDA-approved gene panel that could match one biopsy to several different lung cancer drugs at once.
Overview
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.
Approvals
| 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) |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- 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.
Latest papers
topQuery 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.
Pages like this
not linked directly; found by shared links- ProductGuardant360 CDx
Shares Companion diagnostic, RET, Companion diagnostics, BRAF and the tag test.
- ProductTempus xT CDx
Shares Next-generation sequencing (NGS), Companion diagnostics, EGFR, Comprehensive genomic profiling and the tag test.
- ProductMI Cancer Seek
Shares Next-generation sequencing (NGS), Companion diagnostics, Comprehensive genomic profiling, Non-small-cell lung cancer and the tag test.
- Productcobas EGFR Mutation Test v2
Shares Companion diagnostic, Companion diagnostics, EGFR, Non-small-cell lung cancer and the tag test.
- Producttherascreen companion diagnostic kits (KRAS, EGFR, PIK3CA, FGFR, BRAF)
Shares Companion diagnostic, Companion diagnostics, BRAF, EGFR and the tag test.
- ProductTruSight Oncology Comprehensive
Shares Next-generation sequencing (NGS), Companion diagnostics, Comprehensive genomic profiling and the tag test.
- ProductResolution ctDx FIRST
Shares Companion diagnostics, Non-small-cell lung cancer and the tag test.
- ProductVENTANA PD-L1 (SP263) Assay
Shares Companion diagnostics, Non-small-cell lung cancer and the tag test.