Comprehensive genomic profiling (CGP) solutions

Leverage the depth and breadth of next-generation sequencing for precision oncology.

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Attain deeper insights about solid tumors with CGP

Cancers such as breast cancer, non-small cell lung cancer (NSCLC), and colorectal cancer are complex diseases for which the number of biomarkers and tumor-agnostic treatments are increasing exponentially.1 For precision oncology strategies to be successful, clinicians and researchers must be able to distinguish the actionable genomic alterations in the appropriate disease context.

Comprehensive genomic profiling (CGP) is a next-generation sequencing technology that provides meaningful insights, uncovering the unique molecular signature of each tumor. Unlike single biomarker or hotspot assays, CGP is capable of detecting all four main mutation classes (single nucleotide variants, insertions/deletions, copy number variations, and rearrangements/fusions) known to drive cancer growth across a broad panel of cancer-related genes as well as key complex signatures. As such, it provides prognostic, diagnostic, and predictive insights that inform cancer research and, ultimately, enables precision patient care in a sustainable way.

Technological advances have increased the value of comprehensive genomic profiling to deliver more insights, more quickly, potentially offering significant savings in sample, time, and cost.

Leveraging the FoundationOne® Analysis Platform and the AVENIO workflow, AVENIO Tumor Tissue CGP Kits are part of Roche’s broad oncology portfolio that offers flexible solutions and support services to meet your research needs. With CGP solutions from Roche, you can achieve deeper genomic insights about solid tumors in your own lab, fostering discovery and advancing precision oncology.

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Benefits of comprehensive genomic profiling solutions from Roche

Proven technology

Powered by the expertise and technology of Roche and Foundation Medicine®

The development of high-quality comprehensive genomic profiling assays is technically challenging and requires the integration of deep oncology, technology, and bioinformatics expertise. 

  • Our portfolio of CGP solutions are built on Foundation Medicine’s deep understanding of cancer genomics and its application in clinical practice, supported by Roche’s 125-year legacy of innovation.
  • Roche is a global leader in pharmaceuticals and diagnostics and a pioneer in personalized medicine. We have supported 24 million patients with Roche medicines and delivered 30 billion in vitro diagnostics tests in 2024.2
  • Foundation Medicine has proven expertise in comprehensive genomic profiling, having delivered >1.3 million patient CGP reports and produced 1,000+ peer-reviewed oncology publications.3 In addition, Foundation Medicine send-out solutions have been used in > 500 clinical trials.4
Meaningful insights

Accurate and relevant comprehensive genomic insights

Roche’s comprehensive genomic profiling solutions combine Foundation Medicine’s proven panel design and evidence-based analytics to deliver high-confidence genomic insights and fewer missed opportunities compared to single-biomarker and hotspot testing.

  • The AVENIO Tumor Tissue CGP Kits offer a comprehensive 335-gene panel. Aligned with the FoundationOne® CDx panel design,5,6,7 the kits detect all four major classes of genomic variants: single-base mutations, insertions/deletions, copy number variations, and rearrangements/fusions and detect complex genomic signatures such as tumor mutational burden (TMB), microsatellite instability (MSI), genomic loss of heterozygosity (gLOH), and homologous recombination deficiency signature (HRDsig).6,7,8

  • AVENIO Tissue Tumor CGP kits include the expertly curated FoundationOne® Analysis Platform, a cloud-based secondary analysis software built on Foundation Medicine’s proprietary evidence-based algorithms.

  • Roche CGP solutions also include compatibility with tertiary analysis softwares such as navify® Mutation Profiler, to provide relevant genomic interpretation with biological significance.9
Efficient workflows

Efficient and streamlined NGS workflows

AVENIO comprehensive genomic profiling (CGP) kits offer both manual and automated workflows, providing streamlined, end-to-end solutions from tissue sample to result generation, ensuring simplicity and efficiency.

  • A fast, highly efficient, and safe xylene-free DNA extraction protocol ensures high DNA yields and quality from challenging formalin-fixed paraffin-embedded (FFPE) samples.10,11

  • AVENIO CGP workflows employ an enhanced library preparation protocol with a reduced, one-hour ligation time. This, combined with an optimized target enrichment workflow offering increased multiplexing capabilities, leads to lower per-sample sequencing costs.10,11

  • Roche CGP solutions offer end-to-end, automated data management with the user-friendly AVENIO Connect software (included with the kits). Key features include Human Genome Variation Society (HGVS) annotation, automated data upload and download, and robust customer support.12

  • Both the manual and automated kit workflows enable streamlined, end-to-end workflows, with a less than five-day turnaround time from DNA extraction to result generation.6

AVENIO Tumor Tissue CGP Automated Kit
AVENIO Tumor Tissue CGP Kit V2
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*⸴**
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
Formalin-fixed paraffin-embedded (FFPE) tissue or FFPE tissue-derived DNA
Reagents
REACH compliant, xylene-free, ready-to-use reagents, one-time use only reagent set for automation on the AVENIO Edge System, 24 and 12 reaction pack size*
REACH compliant, xylene-free, ready-to-use reagents in 24 reaction pack size
Sequencing
Illumina NextSeq500/550/550Dx (RUO mode), Illumina NovaSeq6000, Multiplexing of CGP and non-CGP samples possible
Illumina NextSeq500/550/550Dx (RUO mode), Illumina NovaSeq6000, Multiplexing of CGP and non-CGP samples possible
Workflow
Hybrid capture NGS workflow automated on the AVENIO Edge System
Hybrid capture NGS manual workflow
Data Analysis
FoundationOne®Analysis Platform for secondary data analysis; AVENIO Connect for data management; Optimized compatibility with 𝗻𝗮𝘃𝗶𝗳𝘆® Mutation Profiler for tertiary analysis and report generation.‡
FoundationOne®Analysis Platform for secondary data analysis; AVENIO Connect for data management; Optimized compatibility with 𝗻𝗮𝘃𝗶𝗳𝘆® Mutation Profiler for tertiary analysis and report generation.‡
Turn-around Time
Up to 5 days from DNA extraction to result generation*
Up to 5 days from DNA extraction to result generation*

*F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Automated Kit Instructions for Use. (v.2.0). 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.

†F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use. (v.2.0). 2025.

‡F. Hoffmann-La Roche Ltd. navify® Mutation Profiler Instructions for Use. (v2.6). 2025.

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Related health topics

The AVENIO Tumor Tissue CGP Kit portfolio is for Research Use Only. Not for use in diagnostic procedures. 

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. 

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. 

AVENIO Connect Software is for Research Use Only. 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. 

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. 

The AVENIO Connect Software is included in the price of the AVENIO Tumor Tissue CGP Automated Kit. NovaSeq and NextSeq, instruments and associated sequencing reagents, are manufactured and sold by Illumina and are not supplied by Roche

References

  1. Moore D, Guinigundo A. J Adv Pract Oncol. 2023 Apr;14(Suppl 1):15-37.

  2. F. Hoffmann-La Roche Ltd. Investors. [Internet; cited 2025 Aug 16]. Available from: https://www.roche.com/investors.

  3. Foundation Medicine. Products & Services. [Internet; cited 2025 Aug 16]. Available from: https://www.foundationmedicine.com/info/about-our-products-and-services

  4. Foundation Medicine Inc. Data on file.

  5. F. Hoffmann-La Roche. Data on file.

  6. F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use. 2024.

  7. Choi et al. Evolution of a Comprehensive GenomicProfiling (CGP) Kit to Simplify Workflows and Detect Homologous Recombination Deficiency. Poster presented at Association of Molecular Pathology Europe, June 2024.

  8. 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.

  9. F. Hoffmann-La Roche Ltd. navify® Mutation Profiler Instructions for Use. (v2.6). 2024.

  10. F. Hoffmann-La Roche Ltd. AVENIO Tumor Tissue CGP Kit V2 Instructions for Use. June 2024.

  11. F. Hoffmann La Roche. Data on file.

  12. F. Hoffmann-La Roche Ltd. AVENIO Connect Instructions for Use. (v2.2). 2024