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. Read More...
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TruSight Oncology Comprehensive (EU) Kit

20063092

Price
 
 
Services

TSO Comprehensive Enablement Services

20066472

Price
 
 
Accessory Products

TruSight Oncology DNA Control

20065041

Price
 
 

TruSight Oncology RNA Control

20065042

Price
 
 

NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD

20028871

Price
 
 

NextSeq 550Dx Sequencing System

20005715

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
Learn more about the test

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

Method-Specific Workflow Example

 

Supporting Data and Figures

 

Product Literature

TruSight Oncology Comprehensive (EU) example clinical report

Product Information Sheet | PDF < 1 MB

TruSight Oncology Comprehensive (EU)

Data Sheet | PDF 2 MB

Manuals and Support Information

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