Enable CGP with a large pan-cancer panel covering all major variant classes plus gene signatures (TMB, MSI, and HRD) from FFPE tissue.
Assay time
Hands-on time
Input quantity
TruSight Oncology 500 (TSO 500) is an NGS assay that enables in-house comprehensive genomic profiling (CGP) from FFPE tissue.
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.†
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.
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.
Analyze circulating tumor DNA (ctDNA) in blood plasma via liquid biopsy with similar DNA panel content as TruSight Oncology 500.
| Assay time | 4–5 days from sample to results |
|---|---|
| Automation capability | Liquid handling robots |
| 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 |
| 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 |
To run TSO 500 you need:
To analyze with the DRAGEN variant calling pipeline you need:
To generate a final report, you need:
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.
TruSight Oncology 500 Assay
Variant calling:
Insights and reporting:
| 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 |
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.
NGS-based cancer sequencing methods provide more information in less time compared to single-gene and array-based approaches.
| 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) |
| Pan-cancer: BRAF, NTRK1, NTRK2, NTRK3, RET, MSI, TMB | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Genes with biomarkers of significance* | Genes with biomarkers of potential significance† | ||||||||||
 Breast |
BRCA1 | BRCA2 | ERBB2 | ESR1 | PALB2 | PIK3CA | 180 | ||||
 Colorectal |
ERBB2 | KRAS | NRAS | 166 | |||||||
 Bone |
EGFR | ERG | ETV1 | ETV4 | EWSR1 | FEV | FLI1 | FUS | H3F3A | HEY1 | 140 |
| IDH1 | MDM2 | NCOA2 | SMARCB1 | ||||||||
 Lung |
ALK | EGFR | ERBB2 | KRAS | MET | NUTM1 | ROS1 | 223 | |||
 Melanoma |
KIT | NRAS | ROS1 | 172 | |||||||
 Ovarian |
BRCA1 | BRCA2 | FOXL2 | 149 | |||||||
 CNS‡ |
APC | ATRX | CDKN2A | CDKN2B | EGFR | H3F3A | HIST1H3B | HIST1H3C | IDH1 | IDH2 | 140 |
| MYCN | PTCH1 | RELA | TERT | TP53 | |||||||
 Prostate |
AR | ATM | BARD1 | BRCA1 | BRCA2 | BRIP1 | CDK12 | CHEK1 | CHEK2 | FANCL | 151 |
| FGFR2 | FGFR3 | PALB2 | RAD51B | RAD51C | RAD51D | RAD54L | |||||
 Thyroid |
HRAS | KRAS | NRAS | RET | TERT | 165 | |||||
 Uterine & cervical |
BRCA2 | EPC1 | ERBB2 | ESR1 | FOXO1 | GREB1 | JAZF1 | NCOA2 | NCOA3 | NUTM2A | 138 |
| NUTM2B | PAX3 | PAX7 | PHF1 | POLE | SMARCA4 | SUZ12 | TP53 | YWHAE | |||
 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.
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.
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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.
List Price:
Discounts:
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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Discounts:
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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Discounts:
Connected Insights Training - Remote
20092376
Illumina Connected Insights Training - Remote includes five (5) hours of product training delivered virtually.
Informatics Professional Services
20071787
Professional Services rendered for Illumina informatics products and solutions, defined by a statement of work.
Illumina DRAGEN Server v3
20040619
Includes Avance Exchange support for the first year. Requires purchase of annual DRAGEN license.
List Price:
Discounts:
Illumina DRAGEN Server v4
20051343
Includes Avance Exchange support for the first year. Requires purchase of annual DRAGEN license.
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Discounts:
DRAGEN TruSight Oncology 500 HRD Analysis Software, On-Premise
20073738
Includes on-premise analysis software license for TSO 500 HRD.
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.
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.
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).
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.
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.
List Price:
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Insights - Annual Subscription
20090137
Annual subscription to Illumina Connected Insights platform.
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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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.
Advanced chemistry, optics, and informatics combine to deliver exceptional speed and data quality, outstanding throughput and scalability.
Optimized reagent kit that provides increased cluster density and read length, improving sequencing quality scores compared to earlier versions.
Enable CGP with a large pan-cancer panel covering all major variant classes plus gene signatures (TMB, MSI, and HRD) from FFPE tissue.
A fast, integrated workflow for preparing libraries for use in a wide range of sequencing applications.
Comprehensive next-generation sequencing (NGS) assay that targets 170 genes associated with solid tumors.
Comprehensive gene fusion detection covering 507 genes from FFPE and other cancer research samples.
Enable CGP with a large pan-cancer panel covering all major variant classes plus gene signatures (TMB, MSI) from FFPE tissue, with added scalability.
A 58-gene pan-cancer panel with combined DNA content, utilizing the single-tube SLIMamp™ workflow for fast library prep and turnaround time.
Target 1385 cancer genes for gene expression, variant, and fusion detection studies in many RNA sample types, including blood, bone marrow, and FFPE tissue.
Targeted sequencing panel that assesses germline mutations across 113 genes and 125 SNPs associated with genetic cancer risk predisposition.
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