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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 Velsera Clinical Genomics Workspace (CGW).

*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).†

TruSight Oncology 500 High-Throughput

Batch up to 192 samples at a time while using the same panel content and tissue input type as TruSight Oncology 500.

TruSight Oncology 500 ctDNA

Analyze circulating tumor DNA (ctDNA) in blood plasma via liquid biopsy with similar DNA panel content as TruSight Oncology 500.

Learn more about the TruSight Oncology 500 product line

Specifications

Assay time 4–5 days from sample to results
Automation capability Liquid handling robot(s)
Automation details Explore available automation methods
Cancer type 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. 
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.
Hands-on time ~2.5 hr for automated workflow
~10.5 hr for manual workflow
Input quantity 40 ng DNA and/or 40 ng RNA
Instruments NextSeq 550 System, NextSeq 550Dx in Research Mode, NextSeq 500 System
Method Targeted DNA sequencing, Targeted RNA sequencing, Target enrichment
Multiplexing Up to 8-plex
Nucleic acid type DNA, RNA
Sample throughput 8 samples/run
Specialized sample types FFPE tissue
Species category Human
Technology 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

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

1
Prep

TruSight Oncology 500 Assay

2
Sequence
3
Analyze

Variant calling:

Insights and reporting:

Velsera Clinical Genomics Workspace (CGW)

Featured application notes

Analysis of TMB and MSI status with TruSight Oncology 500
Optimizing RNA input to detect gene fusions with TruSight Oncology 500 High-Throughput
Input recommendations for TMB, MSI, and small variant analysis with TruSight Oncology 500

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

Pathology and clinical cancer research

Our clinical cancer research solutions deliver accurate genomic information, and enable labs to analyze multiple genes in a single test.

Immuno-oncology research

Next-generation sequencing enables immuno-oncology researchers to gain insights into immunotherapy response factors and tumor immune evasion mechanisms.

Cancer sequencing methods

NGS-based cancer sequencing methods provide more information in less time compared to single-gene and array-based approaches.

Documentation

Product literature
  • Product information sheet PDF < 1 MB
    2 versions
Support documentation

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 robot(s) Liquid handling robot(s) Liquid handling robot(s)
Automation details Explore available automation methods 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 Velsera 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 NextSeq 1000, NextSeq 2000, NovaSeq 6000, NovaSeq 6000Dx (in research mode) or the NovaSeq X Series. Includes coverage of immuno-oncology biomarker TMB and MSI. Provides a noninvasive research method for 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 hr for automated workflow
~2.5 hr for manual workflow
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 NextSeq 2000 System, NextSeq 1000 System, NovaSeq X System, NovaSeq 6000Dx in Research Mode, NovaSeq 6000 System NovaSeq X 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 NextSeq 1000 and 2000: P2 flow cell 8 samples, P3 flow cell 24 samples, P4 flow cell 36 samples
NovaSeq 6000/Dx: SP flow cell 16 samples, S1 flow cell 32 samples, S2 flow cell 72 samples, S4 flow cell 192 samples
NovaSeq X Series*: 1.5B cartridge 32 samples, 10B cartridge 192 samples, 25B 480 samples		 NovaSeq X Series: 4 samples on 1.5B flow cell, 24 samples on 10B flow cell
NovaSeq 6000 System: 8 samples on S2 flow cell, 24 samples on S4 flow cell, 192 indexes maximum
Nucleic acid type DNA, RNA DNA, RNA DNA
Sample throughput 8 samples/run NextSeq 1000 and 2000: 8-36 samples/run, NovaSeq 6000/Dx: 16-192 samples/run, NovaSeq X: 32-480 samples/run, NovaSeq X Plus: 32-960 samples/run 4-48 samples/run
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 (10)

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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TSO500 DNA/RNA Kit NextSeq (24) plus Illumina Connected Insights Software

20119462

Includes library prep, enrichment reagents and NextSeq reagents plus data interpretation reports (through ICI).

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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 (9)

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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