AVENIO Tumor Tissue Expanded Kit V2

RUO

Extensive range of genes and emerging biomarkers for the profiling of solid tumors

The AVENIO Tumor Tissue Expanded Kit V2 is an NGS research use only assay for expanded profiling of solid tumors in formalin-fixed paraffin-embedded (FFPE) tissue samples. This assay contains 77 genes in the U.S. National Comprehensive Cancer Network (NCCN)¹ and other guidelines, plus 60 emerging biomarkers investigated in clinical trials.

Benefits at a glance

Aligned tissue and plasma analysis when paired with AVENIO ctDNA Expanded Kit V2

Panel content is exactly-matched to gene panel in the AVENIO ctDNA Expanded Kit V2 (same genes, gene regions and hybrid-capture workflow) to facilitate concordant analysis between tissue and plasma, providing the flexibility to switch between tissue and plasma to support a variety of research applications.

Streamlined workflow

The end-to-end research workflow is streamlined across five days, from extraction to analysis and reporting.

Complete research solution

The kit is inclusive of reagents, intuitive analysis, and reporting to facilitate in-house adoption of high-performance NGS oncology testing.

AVENIO Tumor Tissue Expanded Kit V2 analytical performance

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Mutation class	SNVs		Indels		Fusions		CNVs
Mutant allele frequency/copy number	5%		5%		5%		Sample dependent*
Sensitivity and PPV	Sensitivity	PPV	Sensitivity	PPV	Sensitivity	PPV
	>99%	>99%	>99%	>99%	>99%	>99%

* The kit reports ERBB2, EGFR, and MET CNVs. Performance is dependent on various factors, including sample type, input DNA amount, percent tumor content, and the individual tumor’s genomic copy number. Our technical study detected CNVs at dPCR-verified copy numbers, using a commercially available reference sample (50 ng). CNV specificity was high (PPV >99%). ERBB2 detected at 4.5 copies, MET detected at 4.5 copies.
Samples: FFPE tissue curls/sections, DNA input: ≥20 ng of FFPET DNA, total DNA amount for each sample determined by input QC.
Sensitivity and Positive Predictive Value (PPV) metrics based on observed product performance.
Sensitivity and PPV performance reported per variant. Sensitivity was determined using commercially available reference samples containing verified mutations at the stated allele frequencies. SNV performance is panel wide. Indel, Fusion based on whitelist variants. AVENIO Tumor Tissue Analysis Kits V2 achieve >99.99% per base specificity across each of the panels. Stated performance requires at least 20 million reads per sample for Targeted, Expanded, and Surveillance Kits V2. Sequencing performed on an Illumina NextSeq 500/550/550Dx (Research Use Only mode) instrument.

Overview

Ordering information

Key product features

NCCN guideline genes: The assay includes genes in the U.S. National Comprehensive Cancer Network (NCCN) Guidelines¹and other guidelines.

Emerging biomarkers: The assay includes 60 emerging biomarkers investigated in clinical trials.

All mutation classes: All four mutation classes (SNVs, indels, fusions, and CNVs) are included in a single DNA workflow.

AVENIO Tumor Tissue Kits comparison overview

AVENIO Tumor Tissue Targeted Kit V2	AVENIO Tumor Tissue Surveillance Kit V2	AVENIO Tumor Tissue Expanded Kit V2
Disease targets
Lung, Colorectal, Breast, Gastric, Glioma, Melanoma, Ovarian, Thyroid, Pancreatic	Lung, Colorectal, as well as to assess MRD; Secondary: Breast, Gastric, Prostate, Glioma, Melanoma, Ovarian, Thyroid, Pancreatic	Lung, Colorectal, Breast, Gastric, Prostate, Glioma, Melanoma, Ovarian, Thyroid, Pancreatic
Applications
Tumor Profiling 17 genes (81kb); Comprehensive genomic profiling of tumor tissue; Detection of resistance biomarkers.	Tumor Burden Monitoring 471 frequently mutated regions associated with the presence of disease across 197 genes (198 kb), includes 17 genes from targeted panel; Tumor Profiling; Detection of resistance biomarkers; Establishment of a baseline for tumor burden monitoring Detection of minimal residual disease (MRD).	Expanded Tumor Profiling 77 genes (192 kb), includes 17 genes from targeted panel; Tumor Profiling Detection of resistance biomarkers; Investigation of emerging cancer biomarkers.
Sample input
≥20 ng of FFPET DNA	≥20 ng of FFPET DNA	≥20 ng of FFPET DNA
Mutation classes
SNVs, CNVs, Fusions, Indels; from just 20ng of DNA	SNVs, CNVs, Fusions, Indels; from just 20ng of DNA	SNVs, CNVs, Fusions, Indels; from just 20ng of DNA
Performance
Delivers exceptional analytical performance supported by enzymatic error suppression and molecular barcodes⁺	Delivers exceptional analytical performance supported by enzymatic error suppression and molecular barcodes⁺	Delivers exceptional analytical performance supported by enzymatic error suppression and molecular barcodes⁺
Throughput
Up to 24 reportable results per kit	Up to 24 reportable results per kit	Up to 24 reportable results per kit
Time to result
Streamlined workflow < 5 days from tissue DNA extraction to final report	Streamlined workflow < 5 days from tissue DNA extraction to final report	Streamlined workflow < 5 days from tissue DNA extraction to final report
Workflow efficiency
Reduce operational complexity by obtaining reagents for DNA isolation from tissue, library prep, and target enrichment from a single trusted vendor	Reduce operational complexity by obtaining reagents for DNA isolation from tissue, library prep, and target enrichment from a single trusted vendor	Reduce operational complexity by obtaining reagents for DNA isolation from tissue, library prep, and target enrichment from a single trusted vendor
Algorithm
Analyze a variety of solid tumor indications for research using a single optimized DNA workflow for up to 24 samples at a time	Uses an intelligent algorithm that applies population-scale data from multiple cancer databases to design a panel with broad coverage	Analyze a variety of solid tumor indications for research using a single optimized DNA workflow for up to 24 samples at a time
Cost efficiency
Receive a complete solution with the required reagents, a robust bioinformatics pipeline, and software for analysis and reporting to keep your lab at the forefront of cancer research	Receive a complete solution with the required reagents, a robust bioinformatics pipeline, and software for analysis and reporting to keep your lab at the forefront of cancer research	Receive a complete solution with the required reagents, a robust bioinformatics pipeline, and software for analysis and reporting to keep your lab at the forefront of cancer research

^†F. Hoffmann-La Roche Ltd. Data on file.

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AVENIO assays are for Research Use Only. Not for use in diagnostic procedures.

References

National Comprehensive Cancer Network [Internet; cited 2025 Nov 20]. Available from: https://www.nccn.org/
F. Hoffmann-La Roche Ltd. Data on file.

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AVENIO Tumor Tissue Expanded Kit V2

Extensive range of genes and emerging biomarkers for the profiling of solid tumors

Benefits at a glance

AVENIO Tumor Tissue Expanded Kit V2 analytical performance