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) |
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
TruSight Oncology Controls Package Insert (CE-IVDD) Documentation
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