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)|
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.
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.
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
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
Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module v2.3 Workflow Guide (CE-IVDD) Documentation
TruSight Oncology Controls Package Insert (CE-IVDD) Documentation
Custom Protocol Selector
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