TruSight Oncology Comprehensive (EU)
TruSight Oncology Comprehensive (EU) is the first CE-marked IVD, kitted solution for comprehensive genomic profiling (CGP) based on DNA + RNA content.
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Product Highlights
Generate a comprehensive genomic profile of the patient sample
- Detect DNA plus RNA variants and biomarker signatures, such as TMB and MSI, for all multiple solid tumor types
- Increase confidence in ensuring the best treatment decisions
- Consolidate multiple individual biomarkers into a single CGP test, saving sample, time, and costs
Enable targeted therapies and clinical trials
- Content includes key biomarkers associated with drug labels, European Society for Medical Oncology (ESMO) recommendations, and clinical trials for multiple solid tumor types
- Test results help inform therapy decisions according to clinical guidelines
- TruSight Oncology Comprehensive (EU) is also indicated as a companion diagnostic test to identify cancer patients with solid tumors who are positive for NTRK1, NTRK2, or NTRK3 gene fusions, for treatment with VITRAKVI® (larotrectinib) in accordance with the approved therapeutic labeling.
- Under development, an extensive pipeline of additional companion diagnostic claims with the goal of enabling identification of patients likely to respond to specific targeted therapies
Offer the test in your institution
- Rely on a distributed IVD sample-to-answer solution validated by Illumina that can be implemented by local labs
- Broaden potential patient access and reduce turnaround time
- Offer precision oncology in your institution, keep the data in your lab, and avoid losing samples to send-out services, reducing the likelihood of quantity not sufficient (QNS) issues and potentially enabling more informed cases
Intended Use
TruSight Oncology Comprehensive is an in vitro diagnostic test that uses targeted next generation sequencing to detect variants in 517 genes using nucleic acids extracted from formalin-fixed, paraffin embedded (FFPE) tumor tissue samples from cancer patients with solid malignant neoplasms using the Illumina NextSeq 550Dx instrument. The test can be used to detect single nucleotide variants, multi-nucleotide variants, insertions, deletions and gene amplifications from DNA, and gene fusions and splice variants from RNA. The test also reports a Tumor Mutational Burden (TMB) score and Microsatellite Instability (MSI) status.
The test is intended as a companion diagnostic to identify cancer patients for treatment with the targeted therapy listed in Table 1, in accordance with the approved therapeutic product labeling. In addition, the test is intended to provide tumor profiling information for use by qualified healthcare professionals in accordance with professional guidelines and is not conclusive or prescriptive for labeled use of any specific therapeutic product.
| Tumor Type | Biomarkers | Targeted Therapy |
|---|---|---|
| Solid Tumors | NTRK1, NTRK2, and NTRK3 Gene Fusions | VITRAKVI® (larotrectinib) |
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Specifications
Fully automated sequencing and data analysis
TSO Comprehensive workflow—Batch up to seven patient samples and two control samples per run using TSO Comprehensive. The library preparation and enrichment steps take 2 days. The fully automated workflow on the NextSeq 550Dx System sequences samples; performs base calling and QC, variant calling, and interpretation; and generates a clinical report. The entire workflow is complete in 4-5 days.
Variant types and genomic signatures detected by TSO Comprehensive (EU)
Genes with key actionable biomarkers for multiple solid tumor types—Genes listed represent a subset of genes present in the TSO Comprehensive (EU) panel. Content analysis provided by Pierian based on IVD software Knowledge Base v8.5 (February 2023). ‡CNS, central nervous system. *Genes linked to current drug labels or guidelines. †Based on evidence in scientific literature, presence in clinical trials, or linked to labels in other histologies.
Clinical report for TSO Comprehensive—Reported variants are categorized as clinically significant or potentially clinically significant based on an expertly curated knowledge base that includes clinical guidelines, drug labels, clinical trials, and peer-reviewed literature. The easy-to-read output is intended to increase confidence in treatment decisions.
Product Literature
TruSight Oncology Comprehensive (EU) example clinical report
Product Information Sheet | PDF < 1 MB
TruSight Oncology Comprehensive (EU)
Brochure | PDF 3 MB
Data Sheet | PDF | 5 versions
Manuals and Support Information
TruSight Oncology Comprehensive (EU) Package Insert (CE-IVDD) Documentation
TruSight Oncology Comprehensive (EU) Lab Tracking Form (CE-IVDD) Documentation
TruSight Oncology Comprehensive Block List Documentation
TruSight Oncology Controls Package Insert (CE-IVDD) Documentation
Custom Protocol Selector
Generates customized, end-to-end instructions