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.
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.
Assay time
Hands-on time
Input quantity
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TruSight Oncology 500 ctDNA v2 is now available with improved sensitivity using lower cfDNA input, a faster turnaround time, and a more streamlined workflow.
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.
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.
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.
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.
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.
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 Assay
Batch up to 192 samples at a time while using the same panel content and tissue input type 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.
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 |
Cancer type | 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) |
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. |
Gene count | 523 genes for DNA |
Hands-on time | ~1.5-2.5 hr for library prep and enrichment |
Input quantity | 20 ng cfDNA (4 ml of plasma) |
Instruments | NovaSeq 6000 System |
Mechanism of action | Hybrid-capture chemistry |
Method | Targeted DNA sequencing, Target enrichment |
Multiplexing | Up to 8 on S2, and 24 on S4 using Xp-4 Lane workflow, 16 indexes maximum |
Nucleic acid type | DNA |
Specialized sample types | Circulating tumor DNA, Blood |
Species category | Human |
Technology | Sequencing |
Variant class | Single nucleotide variants (SNVs), Insertions-deletions (indels), Copy number variants (CNVs) |
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.
TruSight Oncology 500 ctDNA v2 Assay
*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.
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 |
Next-generation sequencing provides deep insights into the molecular underpinnings of tumors and can help advance the promise of personalized medicine.
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.
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
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.
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.
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.
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.
Lower relative MYC detection due to limit of detection approached faster due to fewer starting copies. Illumina data on file, 2023.
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.
Illumina improved the analysis of circulating tumors with TruSight Oncology ctDNA 500 v2. Learn about new features and benefits in the video.
Interested in learning more about the TruSight Oncology 500 portfolio of products?
Illumina collaborates with National Cancer Center Japan to address a leading cause of death in Asia
Learn about this joint effort to accelerate the development of personalized treatments based on genomic information.
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