Roche Launches NGS AVENIO Tumor Tissue Analysis Kits for Oncology Research

Roche has announced the global commercial launch of three new next-generation sequencing (NGS) AVENIO Tumor Tissue Analysis Kits – the AVENIO Tumor Tissue Targeted Kit, Expanded Kit and Surveillance Kit. The kits, which detect all four mutation classes in solid tumors, complement Roche’s NGS ctDNA kits for oncology research. The AVENIO research-use-only (RUO) portfolio of ready-to-use kits provides reagents and software needed for labs to determine the genomic characteristics of solid tumors through a single DNA workflow.

“With the launch of these innovative assays we are pleased to further empower researchers around the world to continue to advance personalized oncology,” said Michael Heuer, CEO Roche Diagnostics. “These three ready-to-use AVENIO Tumor Tissue Analysis Kits enable researchers by providing relevant panel content that cover all four mutation classes to support the wide variety of cases that require genomic profiling, and complement the previously launched AVENIO ctDNA assays for liquid biopsy.”

Like the AVENIO ctDNA Analysis Kits launched in 2017, the AVENIO Tumor Tissue Analysis Kits are aligned with National Comprehensive Cancer Network (NCCN) guidelines to support oncology research.[2] Researchers can now use the AVENIO family of NGS oncology assays to profile the genomic complexities of a variety of solid tumor types using formalin-fixed paraffin-embedded (FFPE) tissue or plasma to obtain detailed results from either workflow within five days.

“Cancer is a highly complex and dynamic disease, so the ability to obtain a detailed and accurate summary of the genomic profile of malignancies is critical. By combining the new AVENIO Tumor Tissue Kits with ctDNA kits containing exactly matched gene content, Roche has created an innovative new system not only for genomic profiling of solid tumors, but also to better understand how tumor heterogeneity and tumor burden change over time,” said Aadel Chaudhuri, MD, PhD, Assistant Professor of Radiation Oncology at Washington University School of Medicine.

About the AVENIO Tumor Tissue Analysis Kits:

The AVENIO Tumor Tissue Analysis Kits are for research use only and not for use in diagnostic procedures. Three NGS tumor tissue assay kits are now available for oncology research:

• The AVENIO Tumor Tissue Targeted Kit is a 17-gene comprehensive genomic profiling assay for identifying guideline-related biomarkers
• The AVENIO Tumor Tissue Expanded Kit is a 77-gene comprehensive genomic profiling assay with both guideline-related and emerging biomarkers to profile well-characterized genetic mutations in addition to those identified in clinical studies
• The AVENIO Tumor Tissue Surveillance Kit contains 197 genes and is intended for baselining variants in longitudinal tumor burden monitoring applications.

Each kit includes the reagents necessary for DNA extraction and quality control (QC), library preparation and target enrichment. A proactive QC strategy is employed to help labs optimize sample inputs and detect variants in greater than 99% of FFPE samples that pass QC. When paired with secondary analysis software running on the Oncology Analysis Server, labs can analyze sequencing data and generate sequencing QC, variant and analytical concordance reports. The AVENIO kits utilize Roche’s enhanced hybrid capture target enrichment techniques to analyze all four mutation classes in a single DNA workflow: single nucleotide variants (SNVs), insertions or deletions (indels), fusions and copy number variants (CNVs). With the AVENIO family of NGS oncology assays, Roche aims to make sequencing simple and accessible for everyday use.