AVENIO Tumor Tissue CGP Kit V2

RUO For Research Use Only. Not for use in diagnostic procedures.
AVENIO Tumor Tissue CGP Kit V2
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Unlock genomic insights to empower your research and drive precision medicine

The AVENIO Tumor Tissue CGP Kit V2 is an in-house next-generation sequencing (NGS) research use only 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

Benefits at a glance

Benefits at a glance

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Leveraging expertise in personalized medicine and comprehensive genomic profiling: 1000+ peer-reviewed publications, 1.3 million+ CGP reports delivered.1,4

Icon of a gene on a laptop screen representing the genomic coverage of the AVENIO Tumor Tissue CGP Kit V2

Diverse and comprehensive genomic coverage, analyzing 335 relevant genes, four classes of genomic alterations, and complex genomic signatures including tumor mutational burden (TMB), microsatellite instability (MSI), genomic loss of heterozygosity (gLOH), and the newly added homologous recombination deficiency signature (HRDsig).2,3,5

Icon of three arrows joined in a circle representing the fast and complete workflow of the AVENIO Tumor Tissue CGP Kit V2

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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AVENIO Tumor Tissue CGP Kit V2 analytical performance

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AVENIO Tumor Tissue CGP Kit V2 analytical performance

 

Classification 

Detected variants/signatures

Short Variants

99.7%

Rearrangements

89.9%

CNA

99.6%

MSI high

100%

TMB high

100%

gLOH high

100%

HRDsig positive

91.7%
Robust analytical variant detection performance across genomic alterations and signatures.
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). 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.

AVENIO Tumor Tissue CGP Kit V2 specifications

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AVENIO Tumor Tissue CGP Kit V2 specifications

Product specifications 

Value

Panel

335-gene panel aligned with FoundationOne®CDx panel design

Measures 4 genomic alterations based on DNA analysis - SNVs, InDels, REs, and CNAs, along with 4 complex signatures - MSI, TMB, gLOH, and HRDsig*, **  

Sample type

Formalin-fixed paraffin-embedded (FFPE) tissue or FFPE tissue-derived DNA

Reagents

REACH-compliant, xylene-free reagents

24 reaction pack size

Sequencing

Illumina NextSeq 500/550/550Dx (RUO mode): Up to 12 samples in a high-output flowcell*

Illumina NovaSeq 6000; Up to 24 samples in a SP flowcell; Up to 48 samples in a S1 flowcell (exploratory test option)†

Multiplexing of CGP and non-CGP samples in the same flowcell as long as barcodes don’t conflict‡

Workflow

Manual workflow

Data analysis

FoundationOne®Analysis Platform for secondary data analysis
AVENIO Connect Software for data management

Optimized compatibility with navify® Mutation Profiler for tertiary analysis and report generation, although the user can use any tertiary analysis software§

Turn-around time

Up to 5 days from DNA extraction to result generation*

 

* F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Automated Kit Instructions for Use. (v1.0). 2025.
**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.
†F. Hoffmann-La Roche Ltd. AVENIO Connect Instructions for Use. (v2.4). 2025.
‡Ahmed, A., et al. Mixed batching of AVENIO Tumor Tissue CGP samples with various non-CGP sample libraries for enhanced sequencing flexibility. Poster presented at the Association for Diagnostics and Laboratory Medicine (ADLM) Annual Meeting, Chicago, IL, USA, July 2025.
§F. Hoffmann-La Roche Ltd. navify® Mutation Profiler Instructions for Use. (v2.6). 2025.

navify® Mutation Profiler

Simplify NGS tertiary analysis and unlock actionable insights with speed and confidence.

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    Do you have questions about our products or services? We’re here to help. Contact a Roche representative in your region.

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    The AVENIO Tumor Tissue CGP Kit portfolio, including AVENIO Connect Software, is for Research Use Only. Not for use in diagnostic procedures. The AVENIO Connect Software is included in the price of the AVENIO Tumor Tissue CGP Automated Kit.

    navify® Mutation Profiler is CE-IVD in EU. For Research Use Only, not for use in diagnostic procedures in the US and other countries when used with the AVENIO Tumor Tissue CGP Kits. Tertiary analysis with navify® Mutation Profiler is not part of the AVENIO Tumor Tissue CGP Automated Kit and should be purchased as an optional add-on.

    AVENIO Edge reagents and workflows are for Research Use Only when used with the AVENIO Tumor Tissue CGP kit portfolio. Not for use in diagnostic procedures.

    The AVENIO Edge System and consumables are not part of the AVENIO Tumor Tissue CGP Automated Kit and should be purchased as a mandatory add-on.

    References

    1. F. Hoffmann-La Roche Ltd. Data on file.
    2. Choi et al. Evolution of a Comprehensive Genomic Profiling (CGP) Kit to Simplify Workflows and Detect Homologous Recombination Deficiency. Presented at: Association of Molecular Pathology Europe; 2024 Jun 24-26; Madrid, Spain. #ST-19. Available from: https://medically.roche.com/global/en/oncology/amp-eu-2024/medical-material/AMP-EU-2024-poster-zhang-evolution-of-a-comprehensive-pdf.html
    3. F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use. (v1.0). 2024.
    4. Foundation Medicine® Clinical Development and CDx.[Internet; cited 2024 Jul 1]. Available from: https://www.foundationmedicine.com/info/biopharma-overview
    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.