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

~1.5-2.5 hr for library prep and enrichment

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.

TruSight Oncology 500 ctDNA v2 is now available with improved sensitivity using lower cfDNA input, a faster turnaround time, and a more streamlined workflow.

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 minimally invasive blood samples as a complement or alternative to tissue biopsy

  • 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)

  • Achieve ultra-sensitive detection from minimal cfDNA input

  • Get final reports in <4 days from cfDNA with a streamlined workflow

Low-level biomarker detection

Achieve sensitive and accurate detection (0.2% VAF for SNVs) with low inputs (20 ng) using UMI-based hybrid-capture library prep and deep sequencing.

Integrated bioinformatics

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.

Streamlined workflow

Advanced chemistry and extensive workflow optimization enable a single-day library prep plus enrichment for a total turnaround time of <4 days. Automation-friendly kits and methods enable increased efficiencies.

*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 X and NovaSeq 6000Dx (in RUO mode) compatibility to come in 2024.

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


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

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 Pierian 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 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.

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.

Gene count 523 genes for DNA
Hands-on time

~1.5-2.5 hr for library prep and enrichment

~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 6000 System NextSeq 550 System, NextSeq 550Dx in Research Mode, NextSeq 500 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 Up to 8 on S2, and 24 on S4 using Xp-4 Lane workflow, 16 indexes maximum 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)

Nucleic acid type DNA DNA, RNA DNA, RNA
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 X and NovaSeq 6000 Dx compatibility coming in 2024

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

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 (12)

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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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 (2)

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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Software and informatics options (15)

Illumina DRAGEN Server v4

20051343

Includes Avance 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

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Illumina Analytics - 100,000 iCredits

20042042

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Insights - Annual Subscription

20090137

Annual subscription to Illumina Connected Insights platform.

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Illumina Connected Insights - Research – Trial Subscription

20112516

Free trial subscription for Illumina Connected Insights - Research 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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20071787

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Automation (6)

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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TruSight Oncology 500 ctDNA v2 Automation Kit, for Use with NovaSeq 6000 S4 Flow Cell (48 samples)

20105904

Mixed Workflow TSO 500 ctDNA v2 + S4 FC Automated Kit

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TruSight Oncology 500 ctDNA v2 for Automation (48 samples) plus Velsera Interpretation Report

20105906

TSO 500 ctDNA v2 AutomatedKit + Velsera Interpretation Report

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

20105909

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

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TruSight Oncology 500 ctDNA v2 Automation Kit plus Velsera Interpretation Report, for Use with NovaSeq 6000 S4 Flow Cell (48 samples)

20105910

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

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Services (2)

Informatics Professional Services

20071787

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

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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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