TruSight Oncology 500 ctDNA v2

Enable CGP with a pan-cancer panel capable of detecting key IO gene signatures (TMB, MSI) plus all main variant classes from ctDNA in blood plasma.

3-4 days from purified nucleic acid to variant report

Assay time

~1.5 hr for automated workflow ~2.5 hr for manual workflow

Hands-on time

20 ng cfDNA (4 ml of plasma)

Input quantity

See full details in the specifications table

This product is only available in select locations. Please select the location where you would like this product to be shipped to see availability.

Overview

TruSight Oncology 500 ctDNA v2 is a pan-cancer NGS assay that enables in-house comprehensive genomic profiling (CGP) of circulating tumor DNA (ctDNA) in blood plasma for research. 

  • Leverage low cfDNA inputs (20 ng) from minimally invasive blood samples to achieve sensitive and accurate detection (0.2% VAF for SNVs) using UMI-based hybrid-capture library prep and deep sequencing.

  • Target 523 genes to assess DNA variants across major variant classes (SNV, MNV, indels, CNV, and gene rearrangements), plus key immuno-oncology gene signatures (TMB, MSI)

  • Expansion to NovaSeq X Series offers transformative economics, faster sequencing run times by close to 40% and broader batch sizes (4-48 samples)

  • Streamlined workflow with advanced chemistry and automation-friendly kits and method enables a single-day library prep plus enrichment and total turnaround time of 3-4 days.

  • DRAGEN secondary analysis powers a rapid variant calling algorithm on-premises or in the cloud with Illumina Connected Analytics. Access insights using integrated reporting with Illumina Connected Insights* or Velsera.

*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

Maximize chances of identifying an actionable alteration with the TruSight Oncology 500 product line.

TruSight Oncology 500 ctDNA v2

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

 

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


Specifications


Required products

To run TruSight Oncology 500 ctDNA v2, you need:

To analyze with the DRAGEN pipeline, you need:

To generate a final variant report, you need:

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

 Velsera was previously known as Pierian. Other commercial options are available.

/ Results

Applications

Example workflow

*NovaSeq 6000Dx (in RUO mode) on-board compatibility coming soon.

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


Project recommendations

Instrument Recommended number of samples Read length
NovaSeq 6000 System

24 samples per run (S4 flow cell), 800M paired-end reads, 35,000x coverage

2 × 150 bp

NovaSeq 6000 System

8 samples per run (S2 flow cell), 800M paired-end reads, 35,000x coverage

2 × 150 bp

NovaSeq X System

NovaSeq X Series, 4 samples per run (1.5B flow cell), 800M paired-end reads, 35,000x coverage

2 × 150 bp

NovaSeq X System

NovaSeq X Series, 24 samples per run (10B flow cell), 800M paired-end reads, 35,000x coverage

2 × 150 bp


Related applications and methods

Documentation

Product literature

Compare

TruSight Oncology 500 ctDNA v2 TruSight Oncology 500 TruSight Oncology 500 High-Throughput
Analytical sensitivity ≥ 95% (small variants, ≥ 0.5% VAF)
Analytical specificity ≥ 99.995% (small variants, ≥ 0.5% VAF)
Assay time 3-4 days from purified nucleic acid to variant report 4–5 days from sample to results 4–5 days from sample to results
Automation capability Liquid handling robots Liquid handling robots Liquid handling robots
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 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)
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. 
Description 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. 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.
Gene count 523 genes for DNA
Hands-on time ~1.5 hr for automated workflow
~2.5 hr for manual workflow
~2.5 hr for automated workflow
~10.5 hr for manual workflow
~2.5 hr for automated workflow
~10.5 hr for manual workflow
Input quantity 20 ng cfDNA (4 ml of plasma) 40 ng DNA and/or 40 ng RNA 40 ng DNA and/or 40–80 ng RNA
Instruments NovaSeq X System, NovaSeq 6000 System 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
Mechanism of action Hybrid-capture chemistry
Method Targeted DNA sequencing, Target enrichment Targeted DNA sequencing, Targeted RNA sequencing, Target enrichment Targeted DNA sequencing, Targeted RNA sequencing, Target enrichment
Multiplexing 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
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
Nucleic acid type DNA DNA, RNA DNA, RNA
Sample throughput 4-48 samples/run 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
Specialized sample types Circulating tumor DNA, Blood FFPE tissue FFPE tissue
Species category Human Human Human
Technology Sequencing Sequencing Sequencing
Variant class Single nucleotide variants (SNVs), Insertions-deletions (indels), Copy number variants (CNVs) 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)

* Based on Pierian clinical knowledgebase, as of February 2023.

* NovaSeq 6000Dx System in RUO Mode requires a separate, stand-alone DRAGEN server for secondary analysis.

* NovaSeq 6000Dx (in RUO mode) on-board compatibility coming soon

Figures

Small nucleotide variant detection at low VAF

Synthetic control samples with known variant allele frequency (VAF) for each single nucleotide variant were diluted to values ranging from 0.20%–0.50% VAF and analyzed by TruSight Oncology 500 ctDNA v2.

 

Indel detection at low VAF

Synthetic control samples with known VAF for each insertion or deletion were diluted to values ranging from 0.20%–0.50% VAF and analyzed by TruSight Oncology 500 ctDNA v2.

 

High TMB correlation compared to tumor-normal calling

Tumor-only workflow of TSO 500 ctDNA v2 utilizing advanced bioinformatics for germline and CH variant filtering produces highly concordant bTMB compared to a tumor-normal workflow.

 

Sensitive MSI detection for immuno-oncology research

Microsatellite instability (MSI) was evaluated in 3 cell lines with known MSI-high status (samples 1–3) and detected down to 0.3% tumor fraction assessing up to ~2300 homopolymer sites.

 

Analytical performance for CNVs, LOD ≥1.3 fold for amplifications and ≤0.6 for deletions​

Lower relative MYC detection due to limit of detection approached faster due to fewer starting copies.​ Illumina data on file, 2023.

 

Analytical performance for gene rearrangements with detection at LOD (0.5%)​

VAF calculated by dividing the total number of supporting reads by the higher depth of the two sides of the breakpoint. Illumina data on file, 2023.

 

Resources

Thumbnail

TruSight Oncology 500 ctDNA v2 video

Illumina improved the analysis of circulating tumors with TruSight Oncology ctDNA 500 v2. Learn about new features and benefits in the video.

 

TruSight Oncology 500 portfolio brochure

Interested in learning more about the TruSight Oncology 500 portfolio of products?

Manual prep (15)

TruSight Oncology 500 ctDNA v2 (24 samples)

20105899

TSO 500 ctDNA v2 Manual Kit

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TruSight Oncology 500 ctDNA v2 for Use with NovaSeq 6000 S2 Flow Cell (24 samples)

20105901

Mixed Workflow TSO 500 ctDNA v2 + S2 FC Manual Kit

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TruSight Oncology 500 ctDNA v2 for Use with NovaSeq 6000 S4 Flow Cell (24 samples)

20105902

Mixed Workflow TSO 500 ctDNA v2 + S4 FC Manual Kit

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TruSight Oncology 500 ctDNA v2 (24 samples) plus Velsera Interpretation Report

20105905

TSO 500 ctDNA v2 Manual Kit + Velsera Interpretation Report

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TruSight Oncology 500 ctDNA v2 plus Velsera Interpretation Report, for Use with NovaSeq 6000 S2 Flow Cell (24 samples)

20105907

Mixed Workflow TSO 500 ctDNA v2 + S2 FC Manual Kit + Velsera Interpretation Report

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TruSight Oncology 500 ctDNA v2 plus Velsera Interpretation Report, for Use with NovaSeq 6000 S4 Flow Cell (24 samples)

20105908

Mixed Workflow TSO 500 ctDNA v2 + S4 FC Manual Kit + Velsera Interpretation Report

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TruSight Oncology 500 ctDNA Kit (48 samples)

20039252

TruSight Oncology 500 ctDNA Kit (Includes DNA library prep and enrichment reagents. Does not include NovaSeq core reagents)

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TruSight Oncology 500 ctDNA Kit plus Velsera Interpretation Report (16 indexes, 48 Samples) 

20043410

Includes library prep and enrichment reagents, plus data interpretation reports (through Velsera Clinical Genomics Workspace software). Does not include NovaSeq System Core Reagents.

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TruSight Oncology 500 ctDNA Kit, for use with NovaSeq 6000 S2 (48 samples)

20101995

Combination SKU for TSO500 ctDNA and the NovaSeq 6000 S2 Core consumables

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TruSight Oncology 500 ctDNA Kit, for use with NovaSeq 6000 S4 (48 samples)

20101998

Combination SKU for TSO500 ctDNA and the NovaSeq 6000 S4 Core consumables

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TruSight Oncology 500 ctDNA Kit for use with NovaSeq 6000 S2 plus Velsera interpretation report (16 indexes, 48 samples)

20102000

Combination SKU for TSO500 ctDNA and the NovaSeq 6000 S2 Core consumables + Velsera report

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TruSight Oncology 500 ctDNA Kit for use with NovaSeq 6000 S4 plus Velsera interpretation report (16 indexes, 48 samples)

20102001

Combination SKU for TSO500 ctDNA and the NovaSeq 6000 S4 Core consumables + Velsera report

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TruSight Oncology 500 ctDNA v2 (24 samples) plus Illumina Connected Insights Software

20105911

TSO 500 ctDNA v2 Manual Kit + Illumina Connected Insights Software

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TruSight Oncology 500 ctDNA v2 plus Illumina Connected Insights Software, for Use with NovaSeq 6000 S2 Flow Cell (24 samples)

20105913

Mixed Workflow TSO 500 ctDNA v2 + S2 FC Manual Kit+ Illumina Connected Insights Software

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TruSight Oncology 500 ctDNA v2 plus Illumina Connected Insights Software, for Use with NovaSeq 6000 S4 Flow Cell (24 samples)

20105914

TruSight Oncology 500 ctDNA v2 plus Illumina Connected Insights Software, for Use with NovaSeq 6000 S4 Flow Cell (24 samples)

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Index adapters (4)

IDT® for Illumina® UMI DNA/RNA UD Indexes Set A, Ligation (96 Indexes, 96 Samples)

20034701

UMI DNA Index Anchors (Plate = 20027219, Box = 20032119) + Nextera Compatible Unique Dual Index A (Sales Kit = 20027213, Plate = 20025019, Box = 20026121)

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IDT® for Illumina® UMI DNA/RNA UD Indexes Set B, Ligation (96 Indexes, 96 Samples)

20034702

IDT for Illumina UMI DNA Index Anchors Set B

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IDT for Illumina UMI DNA/DNA Index Anchors Set A for Automation

20066404

Includes one box of 96 IDT for Illumina - UMI DNA/RNA UD Indexes Set A for Automation sufficient for labeling 96 samples and one box of 96 IDT for Illumina - UMI DNA Index Anchors for Automation.

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IDT for Illumina UMI DNA/DNA Index Anchors Set B for Automation

20063213

Includes one box of 96 IDT for Illumina - UMI DNA/RNA UD Indexes Set B for Automation sufficient for labeling 96 samples and one box of 96 IDT for Illumina - UMI DNA Index Anchors for Automation.

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Reagents (4)

NovaSeq 6000 S2 Reagent Kit v1.5 (300 cycles)

20028314

Includes one S2 flow cell, one buffer cartridge, one cluster cartridge, and one sequencing cartridge to support a 300-cycle run on the NovaSeq 6000 System.

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NovaSeq 6000 S4 Reagent Kit v1.5 (300 cycles)

20028312

Includes one S4 flow cell, one buffer cartridge, one cluster cartridge, and one sequencing cartridge to support a 300-cycle run on the NovaSeq 6000 System.

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NovaSeq™ X Series 1.5B Reagent Kit (300 Cyc)

20104705

This reagent kit provides one NovaSeq X Series 1.5B flow cell (with 2- lanes) and reagent consumables to support a single flow cell 300 cycles run on the NovaSeq X and NovaSeq X Plus systems.

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NovaSeq X Series 10B Reagent Kit (300 Cycle)

20085594

This reagent kit provides one NovaSeq X Series 10B flow cell (with 8- lanes) and reagent consumables to support a single flow cell 300 cycles run on the NovaSeq X and NovaSeq X Plus systems.

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Software and informatics options (15)

Illumina DRAGEN Server v4

20051343

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

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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 – Trial Subscription

20112516

Free trial subscription for Illumina Connected Insights - for oncology.

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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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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, which may be defined by a pre-determined scope or statement of work.

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Automation (9)

TruSight Oncology 500 ctDNA v2 for Automation (48 samples)

20105900

TSO 500 ctDNA v2 AutomatedKit

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TruSight Oncology 500 ctDNA v2 Automation Kit, for Use with NovaSeq 6000 S2 Flow Cell (48 samples)

20105903

Mixed Workflow TSO 500 ctDNA v2 + S2 FC Automated Kit

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