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TruSight Oncology Comprehensive (EU)

The first CE-marked IVD kitted solution for comprehensive genomic profiling (CGP) of DNA and RNA variants, plus MSI and TMB, for multiple solid tumor types.

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Overview

TruSight Oncology Comprehensive (EU) is a CE-marked IVD next-generation sequencing (NGS)-based CGP for analyzing > 28 solid tumor types using minimal tissue. 

  • Detect DNA plus RNA variants along with biomarker signatures such as TMB and MSI

  • Save time and money by assessing multiple biomarkers in a single test

  • Enable targeted therapies and clinical trials with actionable, easy-to-interpret results

Key biomarkers

Content includes key biomarkers associated with guidelines, drug labels, European Society for Medical Oncology (ESMO) recommendations, and clinical trials.

Companion diagnostic

TruSight Oncology Comprehensive (EU) is indicated as a companion diagnostic (CDx) 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. 

 

Additional companion diagnostic claims are under development.

In-house CGP

Rely on a distributed sample-to-answer solution that can be implemented by local labs. Offer precision oncology in your institution and keep the data and sample in-house, reducing the likelihood of quantity not sufficient (QNS) issues.

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Intended use

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 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, 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. 

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.

Table 1: Companion diagnostics indication

Tumor Type Biomarkers Targeted Therapy
Solid Tumors NTRK1, NTRK2, and NTRK3 gene fusions VITRAKVI® (larotrectinib)

Specifications

Assay time 4-5 days
Content specifications Covers clinically relevant biomarkers across 28+ solid tumors included in 64 clinical guidelines, 111 drug labels, and 615+ clinical trials. Panel content: 517 genes for small variants, 23 genes for fusions, 2 genes for splice variants (MET, EGFR), 2 genes for amplifications (ERBB2, MET), TMB and MSI.
False positive rate by rna variant type
  • RNA Fusions: 0%
  • RNA Splice Variants: 0%
False positives by dna variant type
  • Gene Amplifications: 0% (0/9912)
  • Small DNA Variants: 0.0001% (271/295,801,567)
  • Microsatellite Instability: 0% (0/156)
  • TMB: not applicable as no clinical threshold has been established.
Hands-on time ~10.5 hr
Input quantity

40 ng genomic DNA and 40 ng total RNA 
Instruments NextSeq 550Dx Instrument
Method Target Enrichment, Targeted RNA Sequencing, Targeted DNA Sequencing
Nucleic acid type DNA, RNA
Sample throughput Up to 7 patients and 2 controls (1 positive and 1 NTC) samples per sequencing run
Species category Human
Technology Sequencing

Required products

  • TruSight Oncology Comprehensive (EU) Kit, which includes reagents for 24 DNA and 24 RNA library prep and enrichment reactions
  • A one-time purchase of TruSight Oncology Comprehensive Enablement Services is required for training and workflow instruction
  • DNA and RNA controls for monitoring the analytical performance of the assay
  • NextSeq 550Dx High Output Reagent Kit v2.5 (300 cycles) IVD
  • NextSeq 550Dx Instrument
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Applications

TruSight Oncology Comprehensive (EU) is an in vitro diagnostic test that generates a comprehensive genomic profile of a patient’s tumor, informing therapy decisions according to clinical guidelines.

Example workflow

1
Prep

TruSight Oncology Comprehensive (EU)

2
Sequence
3
Analyze

Local Run Manager TruSight Oncology Comprehensive (EU) Analysis Module (on-instrument software)

Related applications and methods

Comprehensive genomic profiling

This next-generation sequencing approach consolidates hundreds of cancer-related markers, including different variant types, into a single assay.

Oncology

Illumina NGS and microarray technologies for cancer research are helping drive the revolution in cancer genomics.

Documentation

Product literature
Support documentation

Figures

Fully automated sequencing and data analysis

Batch up to seven patient samples and two control samples per run. Library prep and enrichment take 2 days, followed by a fully automated workflow on the NextSeq 550Dx Instrument. The entire workflow takes 4–5 days.

Variant types and genomic signatures detected

Clinical report for TruSight Oncology Comprehensive (EU)

Reported variants categorized as clinically significant or potentially clinically significant based on an expertly curated knowledge base including clinical guidelines, drug labels, clinical trials, and peer-reviewed literature. Easy-to-read output helps increase confidence in treatment decisions.

Genes with key actionable biomarkers for multiple solid tumor types

Pan-cancer: BRAF, NTRK1, NTRK2, NTRK3, RET, MSI, TMB
Genes with biomarkers of clinical significance* Genes with biomarkers of potential clinical significance†
breast cancer
Breast		 BRCA1 BRCA2 ERBB2 ESR1 PALB2 PIK3CA         180
colorectal cancer
Colorectal		 ERBB2 KRAS NRAS               166
bone cancer
Bone		 EGFR ERG ETV1 ETV4 EWSR1 FEV FLI1 FUS H3F3A HEY1 140
IDH1 MDM2 NCOA2 SMARCB1            
lung cancer
Lung		 ALK EGFR ERBB2 KRAS MET NUTM1 ROS1       223
melanoma cancer
Melanoma		 KIT NRAS ROS1               172
ovarian cancer
Ovarian		 BRCA1 BRCA2 FOXL2               149
cns cancer
CNS‡		 APC ATRX CDKN2A CDKN2B EGFR H3F3A HIST1H3B HIST1H3C IDH1 IDH2 140
MYCN PTCH1 RELA TERT TP53          
prostate cancer
Prostate		 AR ATM BARD1 BRCA1 BRCA2 BRIP1 CDK12 CHEK1 CHEK2 FANCL 151
FGFR2 FGFR3 PALB2 RAD51B RAD51C RAD51D RAD54L      
thyroid cancer
Thyroid		 HRAS KRAS NRAS TERT             165
uterine cancer
Uterine & cervical		 BRCA2 EPC1 ERBB2 ESR1 FOXO1 GREB1 JAZF1 NCOA2 NCOA3 NUTM2A 138
NUTM2B PAX3 PAX7 PHF1 POLE SMARCA4 SUZ12 TP53 YWHAE  
other solid cancer tumors
Other Solid Tumors		 ALK APC ARID1A ASPSCR1 ATF1 ATIC BAP1 BCOR BRCA1 BRCA2 152
CAMTA1 CARS CCNB2 CDK4 CDKN2A CIC CITED2 CLTC COL1A1 COL6A3
CREB1 CREB3L1 CREB3L2 CSF1 CTNNB1 DDIT3 DDX3X DNAJB1 DUX4 EED
EGFR ERBB2 ERG ETV1 ETV4 ETV6 EWSR1 FEV FGFR2 FGFR3
FLI1 FOXL2 FOXO1 FOXO4 FUS GLI1 HEY1 HGF HMGA2 IDH1
KRAS LEUTX MAML3 MDM2 MYB MYOD1 NAB2 NCOA2 NF1 NFATC2
NFIB NR4A3 NRAS NUTMI NUTM2A NUTM2B PALB2 PATZ1 PAX3 PAX7
PDGFB PDGFRA PRKACA PRKD1 RANBP2 ROS1 SDHA SDHB SDHC SDHD
SMARCB1 SS18 SSX1 SSX2 SSX4 STAT6 SUZ12 TAF15 TCF12 TERT
TFE3 TFEB TFG TP53 TPM3 TPM4 TRAF7 TSPAN31 VGLL2 WT1
WWTR1 YAP1 YWHAE ZC3H7B            

Genes listed represent a subset of genes present in the TruSight Oncology Comprehensive (EU) panel. Content analysis provided by Pierian based on IVD software Knowledge Base v8.5 (February 2023).  

*Genes linked to current drug labels or guidelines  

†Based on evidence in scientific literature, presence in clinical trials, or linked to labels in other histologies 

‡CNS, central nervous system 

Resources

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Behind every test is a patient

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About TruSight Oncology Comprehensive (EU)

TruSight Oncology Comprehensive (EU) Kit

20063092

Includes reagents for extraction, library preparation, and quantitation of 24 DNA and 24 RNA samples isolated from FFPE. Purchase NextSeq 550Dx sequencing reagents separately.

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TruSight Oncology DNA Control

20065041

Includes a qualitative IVD control for monitoring analytical performance of library prep, sequencing, and analysis.

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TruSight Oncology RNA Control

20065042

Includes a qualitative IVD control for monitoring analytical performance of library prep, sequencing, and analysis.

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

20028871

Includes one high output flow cell, one buffer cartridge, and one reagent cartridge containing clustering and sequencing reagents to support a 300-cycle run on the NextSeq 550Dx System. All products registered for In Vitro Diagnostic sequencing.

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NextSeq 550 Dx Sequencing System

20005715

The NextSeq 550Dx instrument is intended for sequencing of DNA libraries when used with in vitro diagnostic assays performed on the instrument. The NextSeq 550Dx instrument is to be used with specific registered, certified or approved in vitro diagnostic reagents and analytical software. The instrument includes a dual boot configuration to enable the use of the instrument in either diagnostic (Dx) or research use only (RUO) mode. In vitro diagnostic sequencing assays, including the Germline and Somatic Variant Modules, are executed in diagnostic mode. Only IVD sequencing reagents can be utilized in diagnostic mode.

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Services (1)

TSO Comprehensive Enablement Services

20066472

One-time required purchase that includes four days of hands-on training and workflow instruction (library prep, enrichment, sequencing, and data analysis) for up to two operators.

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FAQs

The test was validated across > 350 unique FFPE samples and > 55 different tumor types. Results were compared to orthogonal methods to ensure accurate, reproducible, and consistent results.

Illumina offers a comprehensive support program that provides onboarding to expedite test verification, lab training, verification protocols, training certification, 24/5 technical support, support from our Medical Affairs team for medical inquiries, and educational and marketing assets to share with your local health care providers. Contact your local Illumina Account Manager for more details about the comprehensive support program.

Reimbursement differs based on the country, clinical setting, and services provided. Currently, national or regional funding is available in some European countries. Illumina has established a dedicated Market Access team that is actively working with payers to further expand CGP test reimbursement across the globe. Contact your local Illumina Account Manager with questions about coverage.

Illumina has established multiple partnerships with pharma companies to develop a growing pipeline of CDx indications pending regulatory approvals, that include but are not limited to NTRK (Roche),1 RET (Eli Lilly),2 ROS1 (Roche),1 HRD (Myriad Genetics, Merck),3,4 and MSI (Bristol Myers Squibb).3

The minimum recommended tissue volume is 1 mm3 with a minimum of 20% tumor cell content by area required to detect somatic driver mutations; ≥ 30% tumor content is required to detect MSI-high. A minimum of five biopsy slides is recommended (10 µM sections, 20 mm2 tissue area each).

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Order the NovaSeq X Series

Advanced chemistry, optics, and informatics combine to deliver exceptional speed and data quality, outstanding throughput and scalability.

MiSeq Reagent Kit v3

Optimized reagent kit that provides increased cluster density and read length, improving sequencing quality scores compared to earlier versions.

TruSight Oncology 500

Enable CGP with a large pan-cancer panel covering all major variant classes plus gene signatures (TMB, MSI, and HRD) from FFPE tissue.

Illumina DNA Prep

A fast, integrated workflow for preparing libraries for use in a wide range of sequencing applications.

NextSeq 550Dx Reagents

These sequencing reagent kits offer a simplified workflow and high data quality for in vitro diagnostic testing on the NextSeq550 Dx Instrument.

References

1. Roche, Illumina partner on next-generation sequencing IVD, CDx development, marketing. https://www. genomeweb.com/business-news/roche-illumina-partnernext-generation-sequencing-ivd-cdx-developmentmarketing#.YWhVkhrMKUk. Accessed July 24, 2023.

2. lllumina and Loxo Oncology to partner on developing next-generation sequencing-based pan-cancer companion diagnostics. https://www.businesswire.com/news/home/20180410005649/en/. Accessed July 24, 2023.

3. Illumina announces new and expanded oncology partnerships with Bristol Myers Squibb, Kura Oncology, Myriad Genetics, and Merck to advance comprehensive genomic profiling. https://www.businesswire.com/news/home/20210111005930/en/Illumina-Announces-New-and-Expanded-Oncology-Partnerships-with-Bristol-Myers-Squibb-Kura-Oncology-Myriad-Genetics-and-Merck-to-Advance-Comprehensive-Genomic-Profiling. Accessed July 24, 2023.

4. Illumina partners with Merck to develop and commercialize companion diagnostic and research tests for use in identifying specific cancer mutations. https://www.prnewswire.com/news-releases/illumina-partners-with-merck-to-develop-and-commercialize-companion-diagnostic-and-research-tests-for-use-in-identifying-specific-cancer-mutations-301369838.html. Accessed July 24, 2023.

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