Pan-cancer analysis test kit AVENIO Surveillance V2

for medical researchfor tumour detectionfor cancers

Overview
The AVENIO Tumor Tissue Analysis Kits V2 provide reagents to isolate DNA from formalin-fixed paraffin-embedded (FFPE) tissue, prepare sequencing libraries and enrich selected regions using three panel options:

• AVENIO Tumor Targeted Panel V2 — 17 genes
• AVENIO Tumor Expanded Panel V2 — 77 genes
• AVENIO Tumor Surveillance Panel V2 — 197 genes

These ready-to-use kits use a hybrid-capture DNA workflow to profile genomic alterations from solid tumor FFPE tissue. The kits enable detection of four mutation classes (SNVs, indels, CNVs and fusions) using DNA-only processing and include reagents sufficient for up to 24 reportable results per sequencing run on an Illumina NextSeq 500/550/550Dx (Research Use Only mode).

Benefits at a glance

• Aligned tissue and plasma analysis when paired with AVENIO ctDNA Surveillance Kit V2 — identical panel content and hybrid-capture workflow to support baseline establishment and concordance analysis between tissue and plasma.
• Streamlined end-to-end research workflow — extraction to analysis in approximately five days covering SNVs, indels, fusions and CNVs in a single DNA workflow.
• Complete research solution — reagents for DNA isolation, library preparation and target enrichment combined with analytics and reporting to support in-house NGS oncology research workflows.

Analytical performance (highlights)
Mutation classes and mutant allele frequency / copy number: SNVs — 5% MAF; Indels — 5% MAF; Fusions — 5% MAF; CNVs — sample dependent.
Sensitivity and PPV per variant reported as >99% for SNVs, indels and fusions at the stated allele frequencies; CNV specificity reported high (PPV >99%) in technical study; ERBB2 and MET detected at ~4.5 copies in validation sample.
Performance notes: stated performance requires ≥20 million reads per sample for Targeted, Expanded and Surveillance Kits V2; sensitivity determined using verified reference samples; SNV performance is panel-wide; indel and fusion performance reported for whitelist variants.

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

Characteristics / technical specifications

• Panels available: Targeted (17 genes), Expanded (77 genes), Surveillance (197 genes)
• Workflow: hybrid-capture target enrichment; DNA-only workflow
• Sample type: FFPE tissue curls/sections (formalin-fixed paraffin-embedded tissue)
• Minimum DNA input: ≥20 ng of FFPET DNA (sample- and kit-dependent)
• Throughput: reagents to process up to 24 reportable results per kit (per sequencing run)
• Sequencing platform: Illumina NextSeq 500 / 550 / 550Dx (Research Use Only mode)
• Mutation classes covered: SNVs, indels, fusions, CNVs
• Analytical sensitivity / PPV: >99% reported for SNVs/indels/fusions at 5% MAF (variant- and panel-dependent)
• CNV detection: reports ERBB2, EGFR and MET CNVs; CNV performance is sample dependent (factors include input DNA amount, tumor content, sample type)
• Read depth requirement: stated performance requires ≥20 million reads per sample
• Intended applications: tumor profiling, tumor burden monitoring, baseline establishment for longitudinal monitoring, investigation of resistance biomarkers, minimal residual disease (MRD) research applications