Genetic mutation test kit AVENIO Targeted V2

for tumour detectionfor researchoncology

Overview The AVENIO Tumor Tissue Targeted Kit V2 is a next-generation sequencing (NGS) research-use-only assay for genomic profiling of solid tumors from formalin-fixed paraffin-embedded (FFPE) tissue samples. It contains 17 guideline-aligned biomarkers and uses a hybrid-capture based workflow to profile DNA derived from solid tumor FFPE tissue. The kit supports DNA-only workflows to detect SNVs, indels, CNVs and fusions.

Panels included / options

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

Key benefits

• Guideline-aligned biomarkers (including those listed in NCCN guidelines) for tumor profiling.
• Analytical concordance with AVENIO ctDNA Targeted Kit V2 — panel content is matched enabling aligned tissue and plasma analysis.
• Complete research solution: reagents for DNA isolation from tissue, library preparation, and hybrid-capture target enrichment are provided in the AVENIO Tumor Tissue Analysis Kits V2.
• Streamlined end-to-end research workflow — streamlined across approximately five days from extraction to analysis and reporting.

Analytical performance (summary) The kit delivers high analytical performance supported by enzymatic error suppression and molecular barcodes.
Mutation classes covered: SNVs, Indels, Fusions, CNVs.
Reported mutant allele frequency/copy number threshold for detection (example): 5% for SNVs, Indels and Fusions.
Sensitivity and Positive Predictive Value (PPV) metrics reported: >99% (panel-dependent metrics reported per variant).
Per base specificity: >99.99% across panels (performance requires recommended sequencing depth and sample conditions).
CNV detection: reports ERBB2, EGFR and MET CNVs; CNV performance is sample dependent (example detection at ~4.5 copies in technical study using 50 ng input).

Intended use and workflow

• Research Use Only (RUO) — not for use in diagnostic procedures.
• Intended for genomic profiling of solid tumors using FFPE tissue-derived DNA.
• DNA input: typically ≥20 ng of FFPE DNA (input QC required and total DNA amount determined by input QC).
• Throughput: reagents sufficient for processing up to 24 reactions (reportable results) in a single sequencing run on an Illumina NextSeq 500/550/550Dx instrument (Research Use Only mode).
• Sequencing requirements: stated performance requires recommended sequencing depth (example: ≥20 million reads per sample for Targeted, Expanded, and Surveillance Kits V2).

Benefits at a glance

• Panel content exactly matched to AVENIO ctDNA Targeted Kit V2 enabling tissue/plasma concordance for studies that pair tissue and plasma.
• Streamlined workflow reduces time-to-result and operational complexity.
• Complete research solution with reagents, analysis and reporting capabilities to support in-house NGS oncology research.

Additional technical notes

• Hybrid-capture based enrichment workflow.
• DNA-only workflow (no RNA required for the reported mutation classes).
• Analytical performance metrics (sensitivity, PPV, specificity) are dependent on sample type, DNA input, percent tumor content, sequencing depth, and tumor genomic characteristics.

Characteristics / technical specifications

• Commercial name: AVENIO Tumor Tissue Targeted Kit V2
• Product family: AVENIO (NGS oncology assays)
• Intended samples: FFPE tumor tissue (curls/sections)
• DNA input requirement: ≥20 ng FFPE DNA (input QC determines total DNA)
• Panel size (Targeted): 17 genes (approx. 81 kb)
• Panel options available: Targeted (17 genes), Expanded (77 genes), Surveillance (197 genes)
• Mutation classes detected: SNVs, Indels, Fusions, CNVs (DNA-only workflow)
• Analytical detection threshold example: 5% mutant allele frequency for SNVs, Indels and Fusions
• Sensitivity / PPV: reported >99% for key mutation classes (panel and variant dependent)
• Per-base specificity: reported >99.99% across panels (with required sequencing depth)
• CNV reporting: ERBB2, EGFR, MET (performance dependent on sample and input; example detection at ~4.5 copies in technical study)
• Throughput per kit: up to 24 reportable results per kit / sequencing run
• Recommended sequencing instrument: Illumina NextSeq 500/550/550Dx (Research Use Only mode)
• Typical time to result: streamlined workflow < 5 days from tissue DNA extraction to final report (workflow-dependent)
• Includes: reagents for DNA isolation from FFPE tissue, library preparation, and hybrid-capture target enrichment sufficient for up to 24 reactions
• Regulatory/disclaimer: For Research Use Only. Not for use in diagnostic procedures.