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.

4–5 days from sample to results

Assay time

~2.5 hr for automated workflow~10.5 hr for manual workflow

Hands-on time

40 ng DNA and/or 40 ng RNA

Input quantity

See full details in the specifications table

Overview

TruSight Oncology 500 (TSO 500) is an NGS assay that enables in-house comprehensive genomic profiling (CGP) from FFPE tissue.

  • Targets 523 genes to assess all DNA and RNA variant types (SNV, CNV, indels, fusions), plus MSI, TMB and homologous recombination deficiency (HRD)

  • Delivers accurate results with hybrid–capture chemistry and sophisticated bioinformatics

  • Reduces hands-on time with optional automation kits and methods*

  • Also available in a high-throughput configuration

Thorough results

Evaluate > 500 pan-cancer biomarkers aligned with guidelines and clinical trials to increase chances of finding a positive biomarker with a single assay. Assess genomic instability with the optional add-on HRD kit.

Streamlined workflow

Get results in 4–5 days using manual or automated workflows integrated with ready-to-use DRAGEN secondary analysis pipelines via on-premises server or in the cloud with Illumina Connected Analytics. Access insights and report generation with multiple options, including Illumina Connected Insights or Pierian.

*Not available for TSO 500 HRD.

HRD is only available with the addition of the TruSight Oncology 500 HRD kit to TruSight Oncology 500. Not available in Japan.

Not available in all countries. Illumina Connected Insights supports user-defined tertiary analysis through API calls to third-party knowledge sources.


Enable CGP with a comprehensive portfolio

Identify disease-relevant biomarkers for clinical research with the TruSight Oncology 500 product line.

TruSight Oncology 500

Assess relevant DNA and RNA cancer biomarkers from FFPE tumor tissue, now including HRD through an accessory kit to assess the Genomic Instability Score (GIS).


Specifications


Required products

To run TSO 500 you need:

 

To analyze with the DRAGEN variant calling pipeline you need:

 

To generate a final report, you need:

/ Results

Applications

TruSight Oncology 500 enables comprehensive genomic profiling of FFPE tumor samples to assess a wide range of biomarkers using less sample and yielding more results than single-gene or small panel assays.

Example workflow



Project recommendations

Instrument Recommended number of samples Read length
NextSeq 500 System

8 samples per run (high output flow cell), 100M paired-end reads, 3,500× coverage 

2 × 101 bp

NextSeq 550Dx in Research Mode

8 samples per run (high output flow cell), 100M paired-end reads, 3,500× coverage 

2 × 101 bp


Related applications and methods

Documentation

Product literature

Compare

TruSight Oncology 500 TruSight Oncology 500 High-Throughput TruSight Oncology 500 ctDNA v2
Assay time

4–5 days from sample to results

4–5 days from sample to results

3-4 days from purified nucleic acid to variant report

Automation capability Liquid handling robots Liquid handling robots
Automation details Explore available automation methods Explore available automation methods
Cancer type Pan-Cancer, Solid Tumor Pan-Cancer, Solid Tumor Pan-Cancer, Solid Tumor
Content specifications

Targeted sequencing of DNA from 523 genes and RNA from 55 genes for a total of 1.94 Mb panel size. MSI and TMB measurement included. 

The optional TruSight Oncology 500 HRD kit (not available in Japan) content includes coverage of ~25K SNPs to assess homologous recombination deficiency through a comprehensive genomic instability score (LOH+TAI+LST) powered by Myriad Genetics. 

Targeted sequencing of DNA from 523 genes of interest and RNA from 55 genes, for a total of 1.94Mb panel size. MSI and TMB measurement included. 

Targeted selection of 523 genes (full coding sequence) for a total of 1.94Mb panel size.
• Immuno-oncology biomarker coverage: TMB and MSI
• Guideline coverage: Broad coverage of key guidelines for multiple solid tumor types
• Clinical trial coverage: Over 600 clinical trials (based on Pierian clinical knowledgebase, as of February 2023)
Description

Assay that enables comprehensive genomic profiling from FFPE tissue and runs on the NextSeq 550 System or NextSeq 550Dx Instrument (in Research Mode) and can batch up to eight samples at a time.

A high-throughput comprehensive NGS assay to identify key biomarkers in guidelines and > 1K clinical trials from a streamlined workflow using the NovaSeq 6000 System or NovaSeq 6000Dx Instrument (in Research Mode). Includes coverage of immuno-oncology biomarkers MSI and TMB.

Provides a noninvasive method for profiling solid tumors for cancer research applications through comprehensive genomic profiling of liquid biopsy samples (ctDNA from blood plasma). This liquid biopsy approach provides insights about intra- and inter-tumor heterogeneity using a minimally invasive sample collection approach to complement tissue-based CGP.

Hands-on time ~2.5 hr for automated workflow
~10.5 hr for manual workflow
~2.5 hr for automated workflow
~10.5 hr for manual workflow

~1.5-2.5 hr for library prep and enrichment

Input quantity

40 ng DNA and/or 40 ng RNA

40 ng DNA and/or 40–80 ng RNA

20 ng cfDNA (4 ml of plasma)

Instruments NextSeq 550 System, NextSeq 550Dx in Research Mode, NextSeq 500 System NovaSeq 6000Dx in Research Mode, NovaSeq 6000 System NovaSeq 6000 System
Method Targeted DNA sequencing, Targeted RNA sequencing, Target enrichment Targeted DNA sequencing, Targeted RNA sequencing, Target enrichment Targeted DNA sequencing, Target enrichment
Multiplexing Up to 8-plex

Up to 16-plex (SP flow cell), 32-plex (S1 flow cell), 72-plex (S2 flow cell), and 192-plex (S4 flow cell)

Up to 8 on S2, and 24 on S4 using Xp-4 Lane workflow, 16 indexes maximum
Nucleic acid type DNA, RNA DNA, RNA DNA
Specialized sample types FFPE Tissue FFPE Tissue Circulating Tumor DNA, Blood
Species category Human Human Human
Technology Sequencing Sequencing Sequencing
Variant class Gene fusions, Transcript variants, Single nucleotide variants (SNVs), Insertions-deletions (indels), Copy number variants (CNVs), Loss of heterozygosity (LOH), Somatic variants, Novel transcripts, Single nucleotide polymorphisms (SNPs), Structural variants Gene fusions, Somatic variants, Novel transcripts, Structural variants, Transcript variants, Single nucleotide variants (SNVs), Insertions-deletions (indels), Copy number variants (CNVs) Single nucleotide variants (SNVs), Insertions-deletions (indels), Copy number variants (CNVs)

Figures

TruSight Oncology 500 HRD GIS is concordant to the Myriad Genetics GIS

High-concordance TMB measurement between TSO 500 and WES

Quantitative assessment of MSI status versus MSI-PCR score

Sensitive detection of BRCA large rearrangements, LR (exon-level CNVs)

Small variant calling > 25 bp enabled

Subset of genomic tumor profiling biomarkers for multiple cancer types

Pan-cancer: BRAF, NTRK1, NTRK2, NTRK3, RET, MSI, TMB
Genes with biomarkers of significance* Genes with biomarkers of potential 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 RET 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            

The genes and biomarkers listed in this table are a subset of all genes included in the panel. See the TruSight Oncology 500 data sheet for the full gene list.

* Genes with biomarkers of significance linked to current drug labels or guidelines.

Genes with biomarkers of potential significance based on presence in clinical trials.

CNS, central nervous system. 

References:

1. Data calculations on file. Illumina, Inc. 2023.

Manual prep (9)

TruSight Oncology 500 HRD Kit (24 samples)

20076480

TruSight Oncology 500 HRD Kit (includes HRD enrichment reagents. Does not include library prep or sequencing core reagents. HRD analysis license is required and sold separately.) Not available in Japan.

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TruSight Oncology 500 DNA Kit (48 samples)

20028213

Includes reagents for preparing and enriching up to 48 DNA samples and 16 indexes. Purchase NextSeq 500/550 sequencing reagents separately.

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TruSight Oncology 500 DNA Kit, For Use with NextSeq (48 samples)

20028214

Includes reagents for preparing and enriching up to 48 DNA samples, 16 indexes, and NextSeq 500/550 sequencing reagents.

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TruSight Oncology 500 DNA/RNA Bundle, (16 indexes, 24 samples)

20028215

Includes reagents for preparing and enriching up to 24 DNA and RNA samples and 16 indexes. Purchase NextSeq 500/550 sequencing reagents separately.

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TruSight Oncology 500 DNA/RNA Bundle, for use with NextSeq (16 indexes, 24 samples)

20028216

Includes reagents for preparing and enriching up to 24 DNA and RNA samples and 16 indexes and NextSeq 500/550 sequencing reagents.

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TruSight Oncology 500 DNA Kit plus Velsera interpretation report (16 indexes, 48 Samples)

20032624

Includes reagents for preparing and enriching up to 48 DNA samples, 16 indexes, and data interpretation reports using Pierian Clinical Genomics Workspace. Purchase NextSeq 500/550 sequencing reagents separately.

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TruSight Oncology 500 DNA Kit for Use with NextSeq plus Velsera interpretation report (16 indexes, 48 Samples)

20032625

Includes reagents for preparing and enriching up to 48 DNA samples and 16 indexes, data interpretation reports using Pierian Clinical Genomics Workspace, and NextSeq 500/550 sequencing reagents.

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TruSight Oncology 500 DNA/RNA Bundle plus Velsera interpretation report (16 indexes, 24 Samples) 

20032626

Includes reagents for preparing and enriching up to 24 DNA and RNA samples and 16 indexes and data interpretation reports using Pierian Clinical Genomics Workspace. Purchase NextSeq 500/550 sequencing reagents separately.

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TruSight Oncology 500 DNA/RNA Kit for Use with NextSeq plus Velsera interpretation report (16 indexes, 24 Samples) 

20032627

Includes reagents for preparing and enriching up to 24 DNA and RNA samples and 16 indexes, data interpretation reports using Pierian Clinical Genomics Workspace, and NextSeq 500/550 sequencing reagents.

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Automation (8)

TruSight Oncology 500 DNA Automation Kit (16 indexes, 64 Samples)

20045504

Includes reagents for preparing and enriching up to 64 DNA samples and 16 indexes. Purchase NextSeq 500/550 sequencing reagents separately. Intended for use with automation.

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TruSight Oncology 500 DNA Automation Kit, For Use with NextSeq (16 indexes, 64 Samples)

20045505

Includes reagents for preparing and enriching up to 64 DNA samples and 16 indexes and NextSeq 500/550 sequencing reagents. Intended for use with automation.

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TruSight Oncology 500 DNA Automation Kit plus Velsera interpretation report (16 indexes, 64 samples)

20045506

Includes reagents for preparing and enriching up to 64 DNA samples and 16 indexes and data interpretation reports using Pierian Clinical Genomics Workspace. Purchase NextSeq 500/550 sequencing reagents separately. Intended for use with automation.

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TruSight Oncology 500 DNA Automation Kit plus Velsera interpretation report, for Use with NextSeq (16 indexes, 64 samples

20045507

Includes reagents for preparing and enriching up to 64 DNA samples and 16 indexes, data interpretation reports using Pierian Clinical Genomics Workspace, and NextSeq 500/550 sequencing reagents. Intended for use with automation.

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TruSight Oncology 500 DNA/RNA Automation Kit (16 indexes, 32 Samples)

20045508

Includes reagents for preparing and enriching up to 32 DNA and RNA samples and 16 indexes. Purchase NextSeq 500/550 sequencing reagents separately. Intended for use with automation.

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TruSight Oncology 500 DNA/RNA Automation Kit plus Velsera interpretation report (16 indexes, 32 Samples)

20045509

Includes reagents for preparing and enriching up to 32 DNA and RNA samples and 16 indexes and data interpretation reports using Pierian Clinical Genomics Workspace. Purchase NextSeq 500/550 sequencing reagents separately. Intended for use with automation.

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TruSight Oncology 500 DNA/RNA Automation Kit, For Use with NextSeq (16 indexes, 32 Samples)

20045990

Includes reagents for preparing and enriching up to 32 DNA and RNA samples and 16 indexes and NextSeq 500/550 sequencing reagents. Intended for use with automation.

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TruSight Oncology 500 DNA/RNA Automation Kit plus Velsera interpretation report, For Use with NextSeq (16 indexes, 32 Samples) 

20045991

Includes reagents for preparing and enriching up to 32 DNA and RNA samples and 16 indexes, data interpretation reports using Pierian Clinical Genomics Workspace, and NextSeq 500/550 sequencing reagents. Intended for use with automation.

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Services (4)

TruSight Oncology 500 Training (DNA, optional HRD) - Customer Site

20031667

Three-day, hands-on instruction at customer site to familiarize users with the essential steps in the TruSight Oncology 500 workflow. Course provides hands-on training in sample and library preparation, enrichment, sequencing, and data analysis for a maximum of four trainees.

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TruSight Oncology 500 Training (DNA and RNA, optional HRD) - Customer Site

20031668

3.5-day, hands-on instruction at customer site to familiarize users with the essential steps in the TruSight Oncology 500 workflow. Course provides hands-on training in sample and library preparation, enrichment, sequencing, and data analysis for a maximum of four trainees.

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Connected Insights Training - Remote

20092376

Illumina Connected Insights Training - Remote includes five (5) hours of product training delivered virtually.

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Informatics Professional Services

20071787

Professional Services rendered for Illumina informatics products and solutions, defined by a statement of work.

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Software and informatics options (14)

Illumina DRAGEN Server v3

20040619

Includes Avance Exchange support for the first year. Requires purchase of annual DRAGEN license.

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Illumina DRAGEN Server v4

20051343

Includes Avance Exchange support for the first year. Requires purchase of annual DRAGEN license.

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DRAGEN TruSight Oncology 500 HRD Analysis Software, On-Premise

20073738

Includes on-premise analysis software license for TSO 500 HRD.

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ICA Basic Annual Subscription

20044874

Illumina Connected Analytics (ICA) Basic Annual Subscription. This product includes 1 year of access to ICA Basic, including sequencing instrument connectivity, data management capabilities, and access to pre-packaged analysis tools.

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ICA Professional Annual Subscription

20044876

Illumina Connected Analytics (ICA) Professional Annual Subscription. This product includes 1 year of access to ICA, including sequencing instrument connectivity, data management capabilities, access to pre- packaged tools, and the ability to create customized workflows composed of tools, pipelines, data warehouses, and notebooks.

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ICA Enterprise Annual Subscription

20038994

Illumina Connected Analytics (ICA) Enterprise Annual Subscription. This product includes 1 year of access to ICA Enterprise, including sequencing instrument connectivity, data management capabilities, custom and pre-packaged analysis tools, and the Base module for data warehousing and mining. ICA Enterprise also includes optional HIPAA BAA (US-only), single sign-on (SSO), and a service level agreement (SLA).

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ICA Enterprise Srvc & Compliance Add-on

20066830

Illumina Connected Analytics (ICA) Compliance enables single sign-on (SSO), multi-factor authentication (MFA), HIPAA BAA (US-only), and a Service Level Agreement (SLA) for an ICA Basic Annual Subscription.

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Illumina Analytics - 1 iCredit

20042038

iCredits are used for data storage and analysis on either BaseSpace Sequence Hub or Illumina Connected Analytics.

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Illumina Analytics  Starter Pack - 1,000 iCredits

20042039

iCredits are used for data storage and analysis on either BaseSpace Sequence Hub or Illumina Connected Analytics.

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Illumina Analytics  - 5,000 iCredits

20042040

iCredits are used for data storage and analysis on either BaseSpace Sequence Hub or Illumina Connected Analytics.

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Illumina Analytics  - 50,000 iCredits

20042041

iCredits are used for data storage and analysis on either BaseSpace Sequence Hub or Illumina Connected Analytics.

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Illumina Analytics - 100,000 iCredits

20042042

iCredits are used for data storage and analysis on either BaseSpace Sequence Hub or Illumina Connected Analytics.

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Insights - Annual Subscription

20090137

Annual subscription to Illumina Connected Insights platform.

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Illumina Connected Insights – Oncology Genome Equivalent Sample - VCF

20090138

Illumina Connected Insights pre-paid oncology samples on per genome equivalent basis starting from VCF: one genome is equivalent to 2 exomes, 3 large and 6 small panel samples. Any unused samples will automatically roll over provided that the annual subscription to Illumina Connected Insights (20090137) is renewed on an annual basis. Access to a set of oncology knowledge bases is included.

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FAQs

The primary difference between the assays is scale. TruSight Oncology 500 runs on the NextSeq 550 or NextSeq 550Dx Instrument (in Research Mode) and can batch up to eight samples at a time. TruSight Oncology 500 HT runs on the NovaSeq 6000 System or NovaSeq 6000Dx Instrument (in Research Mode) and can batch 16–192 samples at a time, providing scalability to higher sample throughput. See the comparison table on this page for other differences.

The analysis is optimized for a minimum read length of 2 x 101 bp. Shorter read lengths down to 75 bp may work, but this has not been fully verified.

Yes, you can automate the TruSight Oncology 500 workflow with vendor developed methods.

The Illumina DRAGEN secondary analysis platform delivers greater variant calling accuracy at twice the speed of non-DRAGEN options.1 Increased accuracy provides better performance for sample QC, complex variants, small variants, fusions, and splice variants, as well as exon-level CNV calling for BRCA1/BRCA2. DRAGEN pipelines are also compatible with the TruSight Oncology 500 HRD assay for HRD identification. 

Yes, you can perform analysis with your own software. However, Illumina will not be able to directly provide technical support in this case.

/ Results

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.

Purchasing the Trusight Oncology 500 Assay for the first time?

Complete the form to recieve information about the first-time TruSight Oncology 500 purchase program.