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.1,2

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Benefits at a glance

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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 Kit V2 - Reagent Instructions for Use v3.0. December 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.
‡F. Hoffmann-La Roche. Data on file.
§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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    The AVENIO Tumor Tissue CGP Kit portfolio is for Research Use Only. Not for use in diagnostic procedures.

    AVENIO Connect Software and FoundationOne Analysis Platform are 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 Kit V2.

    navify® Mutation Profiler is for Research Use Only. Not for use in diagnostic proceduress. Tertiary analysis with navify® Mutation Profiler is not part of the AVENIO Tumor Tissue CGP Automated Kit and may 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. F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use v3.0. December 2025.
    3. Foundation Medicine® Clinical Development and CDx.[Internet; cited 2024 Jul 1]. Available from: https://www.foundationmedicine.com/info/biopharma-overview
    4. 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.