Oncomine™ Precision Assay GX

The Oncomine Precision Assay enables simultaneous detection of biomarkers across 50 genes, including key targets within EGFR, BRAF, KRAS, ALK, ROS1, NTRK, RET, and others, from both solid tissue and liquid biopsy samples. The kit provides a targeted pan-cancer panel and library reagents sufficient to perform up to 32 sequencing reactions on the Ion Torrent Genexus Integrated Sequencer using the Ion Torrent GX5 Chip. Additional Genexus Integrated Sequencer reagents and supplies must be ordered separately.

When used with the Oncomine Precision Assay, the Genexus Integrated Sequencer performs library preparation, sequencing, analysis, and reporting in an automated sample-to-result workflow that delivers results in as little as a single day.

The Oncomine Precision Assay includes the following features:

• Compatibility with both FFPE tissue and plasma sample types
• Detection of hotspot mutations (substitutions, insertions, and deletions), copy number variations (CNVs), and gene fusions across 50 cancer driver genes
• FusionSync detection technology, which enables the detection of both targeted isoforms and novel gene fusions
• Sensitive and specific low-level variant detection using Ion AmpliSeqHD chemistry

Sample-to-report in a single day

The full sample-to-result workflow can be completed in a single day, which enables researchers to obtain multi-biomarker results within the same time frame as many traditional single-biomarker tests, such as PD-L1 using IHC.

FusionSync detection technology

The Oncomine Precision Assay uses a synchronous approach for detecting prevalent fusion isoforms and potential novel fusions. The following types of gene fusions can be detected using the FusionSync detection technology:

• Targeted designs for known fusion isoforms, including prevalent isoforms such as EML4-ALK, ETV6-NTRK3, and KIF5B-RET
• Novel combinations of any driver and partner genes included in the panel
• Novel fusions of key driver genes using the exon tiling imbalance method

Curated gene content

Panel content includes relevant pan-cancer genes (data as of December 2019):

• 13 genes in 62 on-market labels
• 19 genes in 26 professional guidelines
• 48 genes used in 1,001 global clinical trials

One kit, multiple applications

The Oncomine Precision Assay GX can be used for multiple analysis approaches:

• Simultaneous DNA- and RNA-based variant analysis for up to 16 FFPE tissue samples
• DNA-only or RNA-only variant analysis for up to 32 FFPE tissue samples
• Cell-free TNA variant analysis (combined DNA and RNA) for up to 32 plasma samples

The Genexus Integrated Sequencer includes system-installed assays for use with the Oncomine Precision Assay. Each system-installed assay is configured with settings that are optimized for the specific application and sample type.

Additional products that are required to complete the workflow include, but are not limited to, the following:

• Genexus Integrated Sequence
• Genexus Templating Strips
• Genexus Sequencing Kit
• Genexus Barcodes 1-32 HD
• Ion Torrent GX5 Chip and Genexus Coupler
• Genexus Pipette Tips

* Timing varies by number of samples and run