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AVENIO Tumor Tissue CGP Kit V2

For Research Use Only. Not for use in diagnostic procedures.

AVENIO Tumor Tissue CGP Kit V2 product image
Accelerate answers to empower life-changing decisions

The AVENIO Tumor Tissue CGP Kit V2 is an in-house next-generation sequencing (NGS) research assay that provides comprehensive genomic profiling of solid tumors from formalin-fixed paraffin-embedded (FFPE) tissue-derived DNA samples. With a 335-gene panel aligned with the FoundationOne®CDx panel design and bioinformatics using the FoundationOne®Analysis Platform, the kit leverages the proven technology of Foundation Medicine and expertise of Roche to help your lab obtain reliable genomic insights.1-3

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Leverage the power of Roche and Foundation Medicine®

Experts in personalized medicine and comprehensive genomic profiling: 800+ peer reviewed publications, 1.3 million+ clinical samples reported.1,4

 

 

 

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Unlock high-quality meaningful genomic insights

Analyzes 335 relevant genes, four classes of genomic alterations, and complex genomic signatures including TMB, MSI, gLOH and the newly added HRDsig.2,3,5

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Utilize fast and convenient NGS workflows

One workflow from DNA extraction to data analysis. Fast 2-day library prep and short 1-hour ligation with a total 5-day turnaround time from DNA extraction to result generation.2,3

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FoundationOne® Analysis Platform + AVENIO Connect Software

The FoundationOne® Analysis Platform processes the AVENIO Tumor Tissue CGP Kit V2 sequencing data from the Illumina NextSeq500/500/550Dx (Research Use Only mode) instruments,* and produces files with filtered variant calls and QC metrics which are made available to the user through AVENIO Connect Software. Leveraging the Foundation Medicine knowledgebase with 1.3 million+ genomic profiles,4 this post-sequencing analysis software makes it easy for customers to analyze samples and access the information they need.2,3

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Robust analytical variant detection performance across genomic alterations and signatures

Sequencing libraries were prepared from 316 FFPE tissue-derived DNA samples on the Illumina NextSeq 550 high-throughput sequencing flowcell using the AVENIO Tumor Tissue CGP Kit V2.2

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Classification

Detected Variants/Signatures

Short Variants

99.7%

Rearrangements

89.9%

CNA

99.8%

MSI high

100% 

TMB high

100% 

gLOH high

100% 

HRDsig positive

91.7%

Results are from 60 million reads per sample on Illumina NextSeq 550 (~12 samples per flowcell) to determine performance by comparing to the reference method (FoundationOne® CDx).2 For this analysis, high or positive signatures were defined as follows: MSI-High ≥ 0.0124, TMB-High ≥ 10.0 mutations/Mb, gLOH-Positive ≥ 0.16, and HRDsig-Positive ≥ 0.7. Samples with scores in the marginal ranges, MSI (0.0041-0.0124; “equivocal” status), TMB (8.0-12.0 mutations/Mb), and gLOH (0.14-0.18), were excluded.The AVENIO Tumor Tissue CGP Kit V2 is a Research Use Only assay and should not be used for diagnostic procedures. Users must determine the complex signature cut-offs based on their research needs. 

High performance as demonstrated by key sequencing metrics

Sequencing libraries were prepared from 316 FFPE tissue-derived DNA samples on the Illumina NextSeq 550 high-throughput sequencing flowcell using the AVENIO Tumor Tissue CGP Kit V2. The graphs show sequencing QC metrics obtained through the FoundationOne® Analysis Platform.2

Graph of AVENIO CGP V2 kit performance over key sequencing metrics

Results are from 60 million reads per sample on Illumina NextSeq 550 (~12 samples per flowcell).2

Strong agreement in allele frequencies and signature scores to the reference method

Sequencing libraries were prepared from 316 FFPE tissue-derived DNA samples on the Illumina NextSeq 550 high-throughput sequencing flowcell using the AVENIO Tumor Tissue CGP Kit V2. Results were compared with the analytical performance with the reference method and are shown.2

Graph of AVENIO CGP V2 kit with strong agreemente in Allele Frequencies

Results are from 60 million reads per sample on Illumina NextSeq 550 (~12 samples per flowcell) to determine performance by comparing to the reference method (FoundationOne® CDx).2 For this analysis, high or positive signatures were defined as follows: MSI-High ≥ 0.0124, TMB-High ≥ 10.0 mutations/Mb, gLOH-Positive ≥ 0.16, and HRDsig-Positive ≥ 0.7. Samples with scores in the marginal ranges, MSI (0.0041-0.0124; “equivocal” status), TMB (8.0-12.0 mutations/Mb), and gLOH (0.14-0.18), were excluded. The AVENIO Tumor Tissue CGP Kit V2 is a Research Use Only assay and should not be used for diagnostic procedures. Users must determine the complex signature cut-offs based on their research needs. 

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  1. Data on file with Roche.
  2. Choi et al. Evolution of a Comprehensive Genomic Profiling (CGP) Kit to Simplify Workflows and Detect Homologous Recombination Deficiency. Poster presented at Association of Molecular Pathology Europe, June 2024. https://medically.roche.com/global/en/oncology/amp-eu-2024/medical-material/AMP-EU-2024-poster-zhang-evolution-of-a-comprehensive-pdf.html
  3. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use June 2024.
  4. Foundation Medicine® Clinical Development and CDx. Available at: https://www.foundationmedicine.com/info/biopharma-overview (Accessed July, 2024)
  5. Chen KT et al. A Novel HRD Signature Is Predictive of FOLFIRINOX Benefit in Metastatic Pancreatic Cancer. Oncologist. 2023 Aug 3;28(8):691-698. doi: 10.1093/oncolo/oyad178.

 

*Illumina NextSeq instruments and associated sequencing reagents are manufactured and sold by Illumina® and are not provided by Roche.
 
AVENIO is a registered trademark of Roche. FOUNDATIONONE is a registered trademark of Foundation Medicine, Inc. All other product names and trademarks are the property of their respective owners.