For Research Use Only. Not for use in diagnostic procedures. Others AVENIO Tumor Tissue CGP Automated Kit RUO AVENIO Tumor Tissue CGP Automated Kit PID00000866 10 265 299 001 10265299001 AVENIO TT CGP Auto SID Primer Kit 4 AVENIO TT CGP Auto SID Primer Kit 4 07613336231258 Reagents, kits Not Available Not Available 10 492 635 001 10492635001 AVENIO TT CGP Automated Kit 1 - 12 rxn AVENIO TT CGP Automated Kit 1 - 12 rxn Other Services Not Available Not Available false 10 247 185 001 10247185001 AVENIO TT CGP Automated Kit 2 - 24 rxn AVENIO TT CGP Automated Kit 2 - 24 rxn Other Services 1 kit for 24 reactions Not Available false 09 789 740 001 9 789 740 001 09789740001 9789740001 09789740001 AVENIO TT CGP Auto Lib & Cap Kit 1-24rxn AVENIO TT CGP Auto Lib & Cap Kit 1-24rxn 07613336222591 Reagents, kits Not Available Not Available 10 247 177 001 10247177001 AVENIO TT CGP Automated Kit 1 - 24 rxn AVENIO TT CGP Automated Kit 1 - 24 rxn Other Services 1 kit for 24 reactions Not Available false 10 492 660 001 10492660001 AVENIO TT CGP Automated Kit 4 - 12 rxn AVENIO TT CGP Automated Kit 4 - 12 rxn Other Services Not Available Not Available false 09 789 731 001 9 789 731 001 09789731001 9789731001 09789731001 AVENIO TT CGP Auto DNA Extraction Kit AVENIO TT CGP Auto DNA Extraction Kit 07613336222614 Reagents, kits Not Available Not Available 09 789 774 001 9 789 774 001 09789774001 9789774001 09789774001 AVENIO TT CGP Auto DNA Quant Kit AVENIO TT CGP Auto DNA Quant Kit 07613336222560 Reagents, kits Not Available Not Available 09 789 758 001 9 789 758 001 09789758001 9789758001 09789758001 AVENIO TT CGP Auto Lib & Capture Kit 2 AVENIO TT CGP Auto Lib & Capture Kit 2 07613336222584 Reagents, kits Not Available Not Available 09 789 766 001 9 789 766 001 09789766001 9789766001 09789766001 AVENIO TT CGP Auto SID Primer Kit 1 AVENIO TT CGP Auto SID Primer Kit 1 07613336222577 Reagents, kits Not Available Not Available 10 247 193 001 10247193001 AVENIO TT CGP Automated Kit 3 - 24 rxn AVENIO TT CGP Automated Kit 3 - 24 rxn Other Services 1 kit for 24 reactions Not Available false 10 265 302 001 10265302001 AVENIO TT CGP Auto SID Primer Kit 2 AVENIO TT CGP Auto SID Primer Kit 2 07613336231265 Reagents, kits Not Available Not Available 10 247 207 001 10247207001 AVENIO TT CGP Automated Kit 4 - 24 rxn AVENIO TT CGP Automated Kit 4 - 24 rxn Other Services 1 kit for 24 reactions Not Available false 09 846 123 001 9 846 123 001 09846123001 9846123001 09846123001 AVENIO TT CGP Auto DNA Cleanup Kit 48rxn AVENIO TT CGP Auto DNA Cleanup Kit 48rxn 07613336222607 Reagents, kits Not Available Not Available false 10 492 643 001 10492643001 AVENIO TT CGP Automated Kit 2 - 12 rxn AVENIO TT CGP Automated Kit 2 - 12 rxn Other Services Not Available Not Available false 10 489 553 001 10489553001 AVENIO TT CGP Auto Lib & Cap Kit 1-12rxn AVENIO TT CGP Auto Lib & Cap Kit 1-12rxn 07613336239056 Reagents, kits Not Available Not Available 10 492 651 001 10492651001 AVENIO TT CGP Automated Kit 3 - 12 rxn AVENIO TT CGP Automated Kit 3 - 12 rxn Other Services Not Available Not Available false 10 265 272 001 10265272001 AVENIO TT CGP Auto SID Primer Kit 3 AVENIO TT CGP Auto SID Primer Kit 3 07613336231241 Reagents, kits Not Available Not Available AVENIO Tumor Tissue CGP Automated Assay is a qualitative, Research Use Only (RUO) product designed for targeted next-generation sequencing of DNA from formalin-fixed, paraffin-embedded tumor tissue specimens. The assay is intended to provide in-house comprehensive genomic profiling information for detection of single nucleotide variations (SNVs), insertion and deletions (InDels), copy number alterations (CNAs), and select gene rearrangements in 335 genes, as well as genomic signatures including microsatellite instability (MSI), tumor mutational burden (TMB), genomic loss of heterozygosity (gLOH), and homologous recombination deficiency-signature (HRDsig), enabling the identification of crucial current and emerging variants and biomarkers across various solid tumors. Each laboratory undertaking this assay is responsible for its analytical validation and for ensuring compliance with relevant international, national, and local laboratory regulations, as well as any other applicable accreditation requirements. en The AVENIO Tumor Tissue CGP Automated Assay (For Research Use Only. Not for use in diagnostic procedures.) utilizes a hybridization-based capture and next-generation sequencing (NGS) workflow to deliver Comprehensive Genomic Profiling (CGP) of solid tumors, covering 2.27 Mb across 335 genes and selected non-coding regions. The AVENIO Tumor Tissue CGP Automated Assay workflow consists of 4 streamlined phases: Tissue Digestion, Automated Library Preparation and Pooling, Sequencing Preparation and Sequencing, Data Analysis and Report Generation. This assay can process a batch of 1-24 specimens per library preparation and library pooling, and accommodate up to 48 specimens per sequencing run. en

AVENIO Tumor Tissue CGP Automated Kit

RUO

Accelerate high-quality genomic insights through automation

The AVENIO Tumor Tissue CGP Automated Kit is a next-generation sequencing (NGS) research use only assay that delivers comprehensive genomic profiling (CGP) of solid tumors.

It automates complex CGP steps including library preparation, target enrichment, on-deck pooling, and quantification using the AVENIO Edge System and seamless bioinformatics enabled by the expertly curated FoundationOne® Analysis Platform.

The AVENIO Tumor Tissue CGP Automated Kit provides a streamlined, end-to-end workflow, from tissue sample to result generation, ensuring simplicity and efficiency¹. It is the result of a collaboration between Roche and Foundation Medicine—two leaders in oncology. This partnership aims to empower researchers to accelerate scientific discovery and innovation in precision oncology.

Set up your AVENIO Edge System before your shift ends

1. Create an AVENIO Edge System work order file that includes detailed sample information

2. Load the instrument with barcoded samples, reagents, and consumables

3. Walk away and return to collect normalized, and sequencing-ready libraries

Benefits at a glance

True walkaway automation

Fully automated AVENIO Edge System for NGS library preparation, target enrichment, on-deck pooling, normalization, and quantification¹
Up to 24 hours of uninterrupted walkaway time to dedicate more attention to higher value tasks¹
Only 3.5 hours of hands-on time for the end-to-end workflow¹

Robust performance

Overcome sample complexity and have confidence in every run with a CGP assay that is extensively validated across >5000 FFPE tumor samples²
Overall sample pass rate of 99.3%^1,2increasing efficiency and reducing the need for retesting
Comprehensive genomic analysis potentially expanding the range of samples suitable for analysis

Insight excellence

Turn data into actionable information with access to an ever-expanding wealth of insights¹
Bring the power of two leaders in oncology, Roche and Foundation Medicine, into your lab^2,4
Comprehensive genomic information and signatures using a 335-gene panel that is aligned with the FoundationOne® CDx panel design¹
Elevate the value of your data with a pan-cancer HRD signature that is aligned with the HRD biomarker, developed and analytically validated in the FoundationOne® CDx assay¹
Future ready-design harnessing the power of FoundationOne® Analysis Platform and AVENIO Connect Software

Product specifications

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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
Sample input	Tumor Content: Minimum 20%, Optimum >30%.* Tissue Area: Minimum 10 mm²; Optimum >25mm.* DNA input: Minimum 40ng; Optimum 300 ng.* Proven data for more challenging samples such as core needle biopsy^†
Reagents	REACH-compliant and free of health-hazardous chemicals. Ready-for-use, one time use only reagent set for automation, 24 and 12 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 an SP flowcell; Up to 48 samples in an S1 flowcell* Multiplexing of CGP and non CGP samples in the same flowcell as long as barcodes don’t conflict†
Workflow	Hybrid capture NGS workflow Automated bead cleanup, library preparation, target enrichment, normalization and pooling with 24h walk away automation in only 3.5h*
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.
Turnaround time	Up to 5 days from DNA extraction to result generation*

SNVs: single nucleotide variants; InDels: insertions and deletions; REs: rearrangements; CNAs: copy number alterations; MSI: microsatellite instability; TMB: tumor mutational burden; gLOH: genomic loss of heterozygosity; HRDsig: homologous recombination deficiency signature
*F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Automated Kit IFU v2.0 May 2025.
†F. Hoffmann-La Roche Ltd. Data on file.
‡F. Hoffmann-La Roche Ltd. AVENIO Connect Software User Assistance version 2.4.1 Software version 2.4.1. December 2025.
¶F. Hoffmann-La Roche Ltd. navify^® Mutation Profiler Instructions for Use. (v2.6). 2025.

Explore the AVENIO Tumor Tissue CGP Automated Kit workflow

Overview

Ordering information

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Document repository

Technical documents

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navify^® Mutation Profiler

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

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This form is provided as a contact service and does not replace the advice of a physician. Roche cannot respond to questions about general medical information or questions regarding your personal medical condition.

Please do not use this form to report complaints or adverse events, or to ask any questions regarding medical products. To report complaints or adverse events, see the information on this page.

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.

*navify® Mutation Profiler is for Research Use Only. Not for use in diagnostic procedures. 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. The AVENIO Connect Software is included in the price of the AVENIO Tumor Tissue CGP Automated Kit.

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.

AVENIO Connect Software is for Research Use Only. Not for use in diagnostic procedures.

References

F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Automated Kit IFU v2.0 May 2025.
F. Hoffmann-La Roche Ltd. Data on file.
Foundation Medicine. Products & Services. [Internet: cited 2025 Dec 11]. Available from: https://vwm.foundationmedicine.com/nfo/about-our-products-and-services.
F. Hoffmann-La Roche Ltd. Oncology. [Internet: cited 2025 Dec 1 1]. Available from: https://wwu.roche.com/solutions/focus-areas/oncology

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Select your user profile

AVENIO Tumor Tissue CGP Automated Kit

Accelerate high-quality genomic insights through automation

Set up your AVENIO Edge System before your shift ends

Benefits at a glance

Product specifications

Product specifications

Explore the AVENIO Tumor Tissue CGP Automated Kit workflow

Overview

Ordering information

Technical documents

Compatible products

navify^® Mutation Profiler

Contact us

User profile

Select your user profile

AVENIO Tumor Tissue CGP Automated Kit

Accelerate high-quality genomic insights through automation

Set up your AVENIO Edge System before your shift ends

Benefits at a glance

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Product specifications

Product specifications

Explore the AVENIO Tumor Tissue CGP Automated Kit workflow

Overview

Ordering information

Technical documents

Compatible products

Related Products

navify® Mutation Profiler

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navify^® Mutation Profiler