TruSight Oncology Comprehensive (EU) is an in vitro diagnostic test that uses targeted next-generation sequencing to detect variants in 517 genes using nucleic acids extracted from 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, multinucleotide 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. TruSight Oncology Comprehensive (EU) is intended as a companion diagnostic to identify patients with solid tumors for treatment with the targeted therapy listed in the table below, in accordance with the approved therapeutic product labeling.
| Tumor type |
Biomarkers |
Targeted therapy |
|---|
Solid Tumors
|
NTRK1, NTRK2, and NTRK3 gene fusions |
VITRAKVI® (larotrectinib)
|
TruSight Oncology Comprehensive HRD (DRAGEN) assesses homologous recombination deficiency (HRD) using DNA extracted from formalin-fixed, paraffin-embedded tumor tissue from ovarian cancer patients. The assay detects mutations in the BRCA1 and BRCA2 genes, including small DNA variants and large gene rearrangements, as well as aberrations that result in structural changes to chromosomes, or "genomic scars," including loss of heterozygosity (LOH), telomeric-allelic imbalance (TAI), and large-scale state transitions (LST), which are indicators of the inability to repair DNA damage. These additional HRD biomarkers can be quantified and summed to generate a genomic instability score (GIS). TruSight Oncology Comprehensive HRD (DRAGEN) is intended to be used as a companion diagnostic to identify cancer patients who may benefit from treatment with the targeted therapy listed in the companion diagnostic indication table, in accordance with the approved therapeutic product labeling.
Further, analysis for TruSight Oncology Comprehensive HRD (DRAGEN) is performed automatically on the NextSeq 550Dx Instrument using the DRAGEN Server and analysis module offering highly optimized algorithms leading to faster turnaround times (TAT) and the ability to analyze more samples per day with the same infrastructure.
