Tumour detection test kit AVENIO CGP V2

for medical researchfor cancersfor research

Overview
The AVENIO Tumor Tissue CGP Kit V2 includes reagents to isolate DNA from FFPE tissue, prepare sequencing libraries, and enrich selected regions of interest using the AVENIO Tumor Tissue CGP Panel V2. The kit includes cloud-based secondary data analysis (FoundationOne® Analysis Platform) and data management software (AVENIO Connect). It uses a hybrid-capture DNA workflow for comprehensive genomic profiling of FFPE solid tumor tissue and enables detection of multiple classes of genomic alterations as well as complex genomic signatures.

Application
In-house next-generation sequencing (NGS) research-use-only (RUO) assay for comprehensive genomic profiling of solid tumors using FFPE tissue-derived DNA. Designed to generate genomics insights from Single-Nucleotide Variants (SNVs), Insertions and Deletions (InDels), Copy Number Alterations (CNAs), Rearrangements, and complex signatures such as Tumor Mutational Burden (TMB), Microsatellite Instability (MSI), genomic Loss of Heterozygosity (gLOH), and Homologous Recombination Deficiency signature (HRDsig).

Benefits at a glance

• Leverage expertise: Built on Foundation Medicine technology and Roche expertise to provide comprehensive genomic profiling with extensive clinical and research experience.
• Diverse, comprehensive genomic coverage: Analyzes 335 relevant genes and multiple alteration classes plus complex genomic signatures (TMB, MSI, gLOH, HRDsig).
• Fast, convenient NGS workflow: One workflow from DNA extraction to data analysis; 2-day library prep, short ligation steps, and up to ~5 day turnaround from DNA extraction to results.

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%

Ordering information / Kit variants

• Material number 10240814001 — AVENIO Tumor Tissue CGP Kit A V2 — Plate A: 24 reactions — EAN: 07613336230862
• Material number 10240822001 — AVENIO Tumor Tissue CGP Kit B V2 — Plate B: 24 reactions — EAN: 07613336230879
• Each kit includes reagents for processing up to 24 reactions, pooled into two to three sequencing runs of up to 8–12 libraries on an Illumina NextSeq 500/550 or NextSeq 550 Dx in RUO mode.

Regulatory disclaimer
For Research Use Only. Not for use in diagnostic procedures.

Features / technical specifications

• Panel: 335-gene panel aligned with FoundationOne® CDx panel design; measures SNVs, InDels, Rearrangements (REs), and CNAs plus signatures MSI, TMB, gLOH and HRDsig.
• Sample type: FFPE tissue or FFPE tissue-derived DNA.
• Reagents: REACH-compliant, xylene-free reagents; 24-reaction pack size.
• Sequencing compatibility: Illumina NextSeq 500/550/550Dx (RUO mode): up to 12 samples per high-output flowcell; Illumina NovaSeq 6000 (exploratory): up to 24 samples in SP flowcell or up to 48 in S1 flowcell; supports multiplexing with non-CGP samples where barcodes do not conflict.
• Workflow: Manual hybrid-capture based workflow from DNA extraction through library prep and enrichment.
• Data analysis: FoundationOne® Analysis Platform for secondary analysis and AVENIO Connect for data management; optimized compatibility with navify® Mutation Profiler for tertiary analysis (optional).
• Turn-around time: Up to 5 days from DNA extraction to result generation (typical workflow and sequencing conditions described by Roche).
• Analytical notes: Performance metrics derived from comparison to FoundationOne® CDx at ~60 million reads per sample (Illumina NextSeq 550) with defined cut-offs for signatures; users should determine signature cut-offs appropriate to their research use.