AVENIO Tumor Tissue Surveillance Kit V2

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

Extensive range of genes for the monitoring of tumor burden

Designed for longitudinal monitoring of tumor burden, the AVENIO Tumor Tissue Surveillance Kit V2 is an NGS research use only assay that complements the AVENIO ctDNA by establishing a baseline from formalin-fixed paraffin-embedded (FFPE) tissue samples. National Comprehensive Cancer Network (NCCN) and other guidelines, as well as an additional 180 genes that are used for tumor burden monitoring and MRD detection in lung cancer and colorectal cancer.

Benefits at a glance

Benefits at a glance

AVENIO Tumor Tissue Surveillance Kit V2 analytical performance

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AVENIO Tumor Tissue Surveillance Kit V2 analytical performance

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.

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AVENIO products 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.