TruSight Oncology Comprehensive
A large gene panel hospitals can run themselves, approved by the FDA in 2024 as a companion diagnostic for the tumour-agnostic drug larotrectinib.
Overview
Illumina's TruSight Oncology Comprehensive is a kit-based, distributable comprehensive genomic profiling test, CE-IVD marked in Europe in 2022 and approved by the FDA in August 2024 with a companion claim for NTRK fusions (larotrectinib) alongside tumour-profiling claims. Unlike send-out services such as FoundationOne CDx, the test is run locally, which shortens turnaround and keeps data in the hospital. It reports tumour mutational burden and microsatellite status, so it also serves the tissue-agnostic pembrolizumab indications, and Illumina has filed additional companion claims.
Approvals
| Region | Year | Indication |
|---|---|---|
| EU | 2022 | CE-IVD comprehensive genomic profiling |
| US | 2024 | Companion diagnostic for larotrectinib (NTRK fusions) with tumour-profiling claims |
Trials
topRecruiting now (live from ClinicalTrials.gov)
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Notes
top- What a result means: the report lists every actionable alteration found; the companion claim is currently for NTRK fusions, while the rest of the findings guide off-label or trial options.
Latest papers
topQuery for this drug: (TITLE:"TruSight Oncology Comprehensive" OR ABSTRACT:"TruSight Oncology Comprehensive" OR TITLE:"TSO Comprehensive" OR ABSTRACT:"TSO Comprehensive") 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 TruSight Oncology Comprehensive, not a curated reading list.
Pages like this
not linked directly; found by shared links- ProductMI Cancer Seek
Shares Next-generation sequencing (NGS), Companion diagnostics, Comprehensive genomic profiling and the tag test.
- ProductTempus xT CDx
Shares Next-generation sequencing (NGS), Companion diagnostics, Comprehensive genomic profiling and the tag test.
- ProductOncomine Dx Target Test
Shares Next-generation sequencing (NGS), Companion diagnostics, Comprehensive genomic profiling and the tag test.
- ProductVENTANA MMR RxDx Panel
Shares Microsatellite instability (MSI-H) / mismatch repair deficiency (dMMR), Companion diagnostics and the tag test.
- ProductResolution ctDx FIRST
Shares Companion diagnostics and the tag test.
- ProductGuardant360 CDx
Shares Companion diagnostics, Comprehensive genomic profiling and the tag test.
- Productcobas EGFR Mutation Test v2
Shares Companion diagnostics and the tag test.
- ProductVENTANA PD-L1 (SP263) Assay
Shares Companion diagnostics and the tag test.