AVENIO Tumor Tissue Targeted Kit V2

RUO For Research Use Only. Not for use in diagnostic procedures.

Guideline-aligned biomarkers for the genomic profiling of solid tumors

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, including those in the U.S. National Comprehensive Cancer Network (NCCN) Guidelines.1

Benefits at a glance

Benefits at a glance

AVENIO Tumor Tissue Targeted Kit V2 analytical performance2

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AVENIO Tumor Tissue Targeted Kit V2 analytical performance2

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%

 

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.
* 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.

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Overview

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Key product features

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

Analytical concordance:The gene panel is matched to the AVENIO ctDNA Targeted Kit V2 assay, facilitating the flexibility to switch between tissue and plasma to support a variety of research applications.

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

References

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