AVENIO Tumor Tissue CGP Kit V2

The AVENIO Tumor Tissue CGP Kit V2 is an in-house next-generation sequencing (NGS) research assay that provides comprehensive genomic profiling from formalin-fixed paraffin-embedded (FFPE) tissue-derived DNA samples. With 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

The power of precision medicine

CGP offers the greatest insights from a single assay leveraging NGS to analyze broad regions of the tumor genome that are often missed by other targeted tests.^6-16

Key assay attributes

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

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

Utilize fast and convenient NGS workflows – One workflow from DNA extraction to data analysis. Fast 2-day library preparation and short 1-hour ligation with a total 5-day turnaround time from DNA extraction to result generation.^2,3

Robust analytical variant detection performance  across genomic alterations and signatures

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

High performance as demonstrated by key sequencing metrics

The graphs show sequencing QC metrics obtained through the FoundationOne® Analysis Platform. Results are from 60 million reads per sample (316 FFPE tissue- derived DNA samples) 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 on the Illumina NextSeq 550 High-throughput sequencing flowcell using the AVENIO Tumor Tissue CGP V2 Kit. Results were compared with the analytical performance with the reference method and are shown.²

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.

References

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 Biopharma services. 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
6. Frampton GM et al. Nat Biotechnol. 2013;31:1023–1031.
7. Suh JH et al. Oncologist. 2016;21:684–691.
8. FoundationOne® CDx Technical Label, 2023. Available at: https://info.foundationmedicine.com/hubfs/FMI%20Labels/FoundationOne_CDx_Label_Technical_Info.pdf (Accessed July 2024).
9. FoundationOne® Liquid Technical Specifications, 2023. Available at: https://assets.ctfassets.net/w98cd481qyp0/wVEm7VtICYR0sT5C1VbU7/fd055e0476183a6acd4eae6b583e3a00/F1LCDx_Technical_Specs_072021.pdf (Accessed July 2024).
10. FoundationOne® Heme Technical Specifications, 2021. Available at: https://assets.ctfassets.net/w98cd481qyp0/42r1cTE8VR4137CaHrsaen/baf91080cb3d78a52ada10c6358fa130/FoundationOne_Heme_Technical_Specifications.pdf (Accessed July 2024).
11. He J et al. Blood. 2016;127:3004–3014.
12. Clark TA et al. J Mol Diagn. 2018;20:686–702.
13. Chalmers ZR et al. Genome Med. 2017;9:34.
14. Schrock AB et al. Clin Cancer Res. 2016;22:3281–3285.
15. Ross JS et al. Gynecol Oncol. 2013;130:554–559.
16. Hall MJ et al. J Clin Oncol. 2016;34:1523–1523.