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TruSight Oncology Comprehensive IVD Solutions

Maximize actionable biomarker content

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

Two diverse female healthcare providers standing in an office hallway, one holding a tablet, having a discussion.

One test.
One report.
One goal.

TruSight Oncology Comprehensive products are IVD test kits 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

Key features and benefits

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.

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.

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.

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.

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.

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 Comprehensivea products:

Pan-cancer genes: BRAF NTRK1 NTRK2 NTRK3 RET

Genes with biomarkers of significance
  Breast AKT1 BRCA1 BRCA2 ERBB2 ESR1 PALB2 PIK3CA PTEN
  Colorectal ERBB2 KRAS NRAS          
  Bone EGFR ERG ETV1 ETV4 EWSR1 FEV FLI1 FUS
H3F3A HEY1 IDH1 MDM2 NCOA2 SMARCB1    
  Lung ALK EGFR ERBB2 KRAS MET NUTM1 ROS1  
  Melanoma KIT NRAS ROS1          
  Ovarian BRCA1 BRCA2 CTNNB1 ERBB2 FOXL2 TP53    
  CNS ATRX CDKN2A CDKN2B EGFR H3F3A HIST1H3C IDH1 IDH2
MYCN NF1 PTCH1 TERT TP53      
  Prostate ATM ATR BARD1 BRCA1 BRCA2 BRIP1 CDK12 CHEK1
CHEK2 FANCA FANCL FGFR3 MLH1 MRE11 NBN PALB2
PTEN RAD51B RAD51C RAD51BD RAD54L TACC3    
  Thyroid HRAS KRAS NRAS TERT        
  Uterine BRCA2 EPC1 ERBB2 ESR1 FOXO1 GREB1 JAZF1 NCOA2
NCOA3 NUTM2A NUTM2B PAX3 PAX7 PHF1 POLE SMARCA4
SUZ12 TP53 YWHAE          
  1. TruSight Oncology Comprehensive products also contain 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 (content analysis provided by Velsera Knowledgebase v8.17, March 2024). These genes are in addition to the genes with biomarkers of clinical significance linked to current drug labels or guidelines.

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.

Step 1: Sample specimen

TruSight Oncology Comprehensive products provide more information from less sample, in less total time compared to current iterative testing methods.

Step 2: DNA and RNA extraction

TruSight Oncology Comprehensive products can use DNA and RNA extracted simultaneously from the same sample as input material. (Extraction kits must be purchased separately).

Step 3: Library preparation

Library preparation is based on proven hybrid–capture chemistry using biotinylated probes and streptavidin- coated magnetic beads to purify selected targets from DNA- and RNA-based libraries.

Scientist starting sequencing run on NextSeq 550Dx Instrument

Step 4: Sequencing to clinical report

Test results, supported by an expertly curated Knowledgebase, are presented in a single, streamlined results report.

Fully automated workflow on-instrument

  1. Sequencing
  2. Base calling and QC
  3. Variant calling
  4. Interpretation and final report: Get a clear, easy-to-read, clinically relevant final report that accurately identifies actionable mutations and can help inform therapy decisions.
View sample TSO Comprehensive report

Pipeline of companion diagnostic indications under development

TruSight Oncology Comprehensive products are indicated as companion diagnostic tests. 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.

health leader innovating precision health
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Comprehensive genomic profiling eBook

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

The power of in-house CGP

  • Offer a turnaround time of 4-5 days versus multiple weeks for sendout 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
Female scientist, front side view, holding clear liquid in tube, recording data

Resources

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Precision medicine unlocked for all

In this video, healthcare experts discuss how CGP 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.

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.

Reference

  1. Content analysis provided by Pierian Knowledgebase v8.5, February 2023.