Oncomine™ Comprehensive Assay v3C

The Oncomine Comprehensive Assay v3 is a targeted, next-generation sequencing (NGS) assay that enables the detection of relevant SNVs, CNVs, gene fusions, and indels from 161 unique genes to help inform drug discovery resea?ch and clinical trial research programs. It provides the reagents for library construction and four pools - two DNA and two RNA - of multiplex PCR primers for preparation of amplicon libraries from formalin-fixed paraffin embedded (FFPE) tumor samples. Designed to help you go from hundreds down to a few relevant cancer drivers, this assay is part of a comprehensive workflow that enables NGS data analysis from as little as 10 ng of nucleic acid per pool. The assay is optimized for sequencing on the Ion GeneStudio S5 Systems with the Ion 540 Chip to enable up to 8 samples (7 samples and one no-template control) per run.

When combined with Oncomine Reporter Software, you can create reports that align labels, guidelines, and clinical trials to your results so you can focus on key drivers of cancer in your research.

Key features of the assay are:

• Enables analysis of variants across 161 genes
• Detection of SNVs, CNVs, gene fusions, and indels
• Robust performance from as little as 10 ng per pool (40 ng total) isolated from FFPE samples including fine needle biopsies
• Characterized with molecular standards and controls
• Content driven by the Oncomine Knowledgebase and experienced scientists helps assure coverage of key targets aligned to published evidence

From sample to answer

The Oncomine Comprehensive Assay is part of an NGS workflow that helps researchers to filter variant results from hundreds to just a few key cancer driver variants. Enabled by Oncomine Informatics, this filtering, as well as the annotations from on-market labels, established guidelines (US-NCCN, US-FDA, EMSO, EMA), and global clinical trials, helps you contextualize and interpret findings to move toward the answers you need.

The workflow has been adopted by large-scale national clinical trial research programs including NCI-MATCH (United States) and LC-SCRUM (Japan), and includes:

• Proven Ion AmpliSeq chemistry
• Automated library and template prep on the Ion Chef System
• Scalable sequencing on the Ion GeneStudio S5 Systems
• Optimized Oncomine informatics

Multiple configurations

The Oncomine Comprehensive Assay v3 comes in the following configurations to match your laboratory needs:

Manual library preparation configuration:

Oncomine Comprehensive Library Assay v3M

This configuration contains all the reagents needed to prepare libraries for 24 or 96 samples:

• Oncomine Comprehensive Panel v3M DNA - contains the DNA primer pools
• Oncomine Comprehensive Panel v3M RNA - contains the RNA primer pools
• Ampliseq Library Plus reagents - allow you to manually create your library

Ion Chef automated library preparation configuration:

Oncomine Comprehensive Library Assay v3C

This configuration contains all the reagents needed to prepare libraries for 32 samples:

• Oncomine Comprehensive Panel v3C DNA - contains the DNA primer pools
• Oncomine Comprehensive Panel v3C RNA - contains the RNA primer pools
• Ion AmpliSeq Kit for Chef DL8 reagents - allows you to automate library prep on the Ion Chef System