Lung cancer test kit AVENIO ctDNA V2

for researchcolorectal cancerfor cfDNA

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

Overview
The AVENIO ctDNA Surveillance Kit V2 is a next-generation sequencing (NGS) liquid biopsy research assay designed and optimized for longitudinal tumor burden monitoring in lung cancer and colorectal cancer research. The Surveillance panel enables identification, profiling and monitoring of genomic alterations across a broad set of cancer-related genes and regions. The kit package includes reagents, analysis software, and bioinformatics necessary to uncover genomic aberrations in solid tumors; an Oncology Analysis Server to run the bioinformatic pipeline is required.

Intended applications

• Longitudinal tumor burden monitoring (lung cancer, colorectal cancer)
• Non-invasive tumor profiling and serial monitoring
• Detection of a wide range of mutation classes (SNVs, indels, fusions, CNVs)

Workflow (high-level)

• Isolate cfDNA from plasma (AVENIO cfDNA Isolation Kit V2)
• Prepare sequencing libraries (AVENIO ctDNA Library Prep Kit V2)
• Perform target enrichment (AVENIO ctDNA Enrichment Kit V2)
• Use one of the AVENIO ctDNA Panels (Targeted, Expanded, Surveillance) and AVENIO Post-Hybridization Kit V2
• DNA sequencing

Benefits at a glance

• Exceptional analytical performance: Analytical performance is supported by integrated digital error suppression (iDES) strategies combining molecular barcodes with in silico error suppression techniques to improve detection of low-frequency variants.
• Streamlined workflow: End-to-end research workflow streamlined across approximately five days from extraction to analysis and reporting.
• Comprehensive research: Test a wide range of genes and mutation classes in a single assay — broad coverage to support tumor burden monitoring, profiling and detection of resistance biomarkers.

Key product features

• NCCN guideline genes: assay includes genes referenced in the U.S. National Comprehensive Cancer Network (NCCN) Guidelines.
• All mutation classes: single assay detects SNVs, indels, fusions and CNVs.
• Comprehensive package: reagents, bioinformatics pipeline and software are provided as part of the AVENIO ctDNA Analysis Kits V2 solution.

Analytical performance (summary)
Mutation class | Reported limit / sensitivity notes
SNVs: reported sensitivity at 0.5% AF (for 50 ng DNA input) — Sensitivity >99%, PPV >95%
Indels: reported sensitivity at 1.0% AF (for 50 ng DNA input) — Sensitivity >99%, PPV >99%
Fusions: reported sensitivity at 1.0% — Sensitivity >99%, PPV >99%
CNVs: sample dependent; kit reports ERBB2, EGFR and MET CNVs; performance dependent on sample type, input DNA amount, tumor content and genomic copy number (CNV specificity reported PPV >99% in technical study).

Notes on sensitivity and inputs
The reported sensitivity and PPV metrics reference performance with 50 ng DNA input at stated allele frequencies. The kit can report variants down to 0.1% AF (with lower sensitivity) and can make libraries with as low as 10 ng input. Stated performance requires sufficient sequencing depth (e.g., ~40 million reads per sample for AVENIO ctDNA panels V2) and sequencing on compatible Illumina instruments in Research Use Only mode.

Downloads & documentation (available)
Gene list, software brochure and product brochure are provided as technical documents associated with the product (PDF documents listed in product downloads).