TruSight Oncology IVD Solutions

TruSight Oncology Comprehensive IVD Solutions

Maximize actionable biomarker content

Bring precision medicine to your lab with an IVD kitted CGP solution

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One test. One report. One goal.

TruSight Oncology Comprehensive is an IVD test for comprehensive genomic profiling (CGP) based on DNA and RNA, consolidating multiple iterative tests into one. Using a single test for hundreds of current and emerging biomarkers, including a pan-cancer companion diagnostic, qualified healthcare professionals can access a clinically relevant report with actionable results to help redefine the journey for patients with cancer.

Learn how this IVD test can help guide personalized care decisions by maximizing actionable biomarker content in a single test to help drive better outcomes through precision medicine.

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TruSight Oncology Comprehensive products


TruSight Oncology Comprehensive (EU)

CE-marked marked IVD kitted solution for comprehensive genomic profiling (CGP) for multiple solid tumor types.

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TruSight Oncology Comprehensive (US)

FDA approved IVD kitted solution for comprehensive genomic profiling (CGP) for multiple solid tumor types. 

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Key features and benefits

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Generate genomic profiles

Get mutational information on more than 500 genes to match patients with optimal therapeutic options. Detect DNA and RNA variants plus genomic signatures across multiple solid tumor types.

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Help inform critical decisions

Test results help inform therapy decisions according to clinical guidelines. Content includes key biomarkers associated with drug labels, major clinical guideline recommendations, and clinical trials.

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Offer in-house testing

Keep data in-house and avoid losing samples to send-out services. A streamlined four- to five-day sample-to-answer workflow helps serve more patients locally.

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Conserve biopsy samples

Minimize risk of quantity not sufficient (QNS) issues by maximizing the genetic insights from each sample with comprehensive genomic coverage from a single test.

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Consolidate multiple tests

Get comprehensive results in a single easy-to-interpret report, without waiting weeks for sequential results from separate tests. Leverage NGS to interrogate potential variants across different classes in a single test.

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Maximize actionability

Obtain coverage of multiple variant classes in coding regions of cancer-related genes and genomic signatures. Stay ahead of expanding guidelines and new scientific literature with a comprehensive assay.

Key genes

Selection of key genes detected by TruSight Oncology Comprehensive includes:

PAN-CANCER GENES:

BRAF NTRK1 NTRK2 NTRK3 RET
breast cancerBreast AKT1 BRCA1 BRCA2 ERBB2 ESR1 PALB2 PIK3CA PTEN      
colorectal cancerColorectal ERBB2 KRAS NRAS                
bone cancerBone EGFR ERG ETV1 ETV4 EWSR1 FEV FLI1 FUS H3F3A HEY1 IDH1
MDM2 NCOA2 SMARCB1                
lung cancerLung ALK EGFR ERBB2 KRAS MET NUTM1 ROS1        
melanoma cancerMelanoma KIT NRAS ROS1                
ovarian cancerOvarian BRCA1 BRCA2 CTNNB1 ERBB2 FOXL2 TP53          
cns cancerCNS ATRX CDKN2A CDKN2B EGFR H3F3A HIST1H3C IDH1 IDH2 MYCN NF1 PTCH1
TERT TP53                  
prostate cancerProstate ATM ATR BARD1 BRCA1 BRCA2 BRIP1 CDK12 CHEK1 CHEK2 FANCA FANCL
FGFR3 MLH1 MRE11 NBN PALB2 PTEN RAD51B RAD51C RAD51BD RAD54L TACC3
thyroid cancerThyroid HRAS KRAS NRAS TERT              
uterine cancerUterine BRCA2 EPC1 ERBB2 ESR1 FOXO1 GREB1 JAZF1 NCOA2 NCOA3 NUTM2A NUTM2B
PAX3 PAX7 PHF1 POLE SMARCA4 SUZ12 TP53 YWHAE      

*TruSight Oncology Comprehensive also contains many genes with biomarkers of potential clinical significance based on scientific literature evidence, presence in clinical trials, or linked to labels or guidelines in other histologies.1 These genes are in addition to the genes with biomarkers of clinical significance linked to current drug labels or guidelines.

1Content analysis provided by Velsara Knowledgebase v8.17, March 2024.

From sample to report in just 4-5 days

Implement a streamlined, IVD sample-to-answer solution, empowering you to generate accurate test results locally and improve the chances patients will be matched to targeted therapies or clinical trials.

TSO Workflow

*Extraction kits must be purchased separately.

Pipeline of companion diagnostic indications under development

TruSight Oncology Comprehensive is indicated as a companion diagnostic test. See the product’s package insert for information on approved indications.  Illumina has partnered with pharma companies to develop a growing pipeline of additional companion diagnostic indications. 

Comprehensive genomic profiling eBook

Learn how one biopsy, one test, and one report can lead to improved patient outcomes.

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The power of in-house CGP

  • Offer a turnaround time of 4-5 days versus multiple weeks for send-out testing
  • Automatically generate an intuitive report by leveraging integrated, on-board design
  • Streamline implementation efforts with validated IVD reagents
  • Maintain control of the original samples and data; reanalyze data when a new guideline, drug, or clinical trial becomes available
  • Improve access by offering tests at locations closer to the patient
Resources
Precision medicine unlocked for all

In this video, our healthcare experts discuss how comprehensive genomic profile testing maximizes the information available in each tissue sample and helps support precision medicine as the new standard of care.

Bring cancer into focus with CGP

Learn more about CGP and its benefits in identifying potentially clinically relevant genomic alterations across a variety of tumor types.

CGP empowers broader access to precision oncology

Download this infographic and see how CGP can improve detection of actionable genomic alterations in just one test.

Speak to a specialist

Contact an Illumina representative to learn more about the TruSight Oncology product line and find the right solutions for your needs.

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