Oncomine™ Precision Assay GX
Oncomine™ Precision Assay GX
Ion Torrent™

Oncomine™ Precision Assay GX

The Oncomine Precision Assay enables simultaneous detection of biomarkers across 50 genes, including key targets within EGFR, BRAF, KRAS, ALK,Read more
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Catalog number A46291
Price (USD)
6,890.00
Each
Add to cart
Price (USD)
6,890.00
Each
Add to cart
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

Specifications
Sample TypeFFPE, Plasma
Sequencing TypeNext Generation Sequencing
For Use With (Application)Sequencing
LibrariesAmplicon based
Nucleic Acid TypeDNA, RNA, and cfTNA
No. of Samples16 FFPE samples for DNA and RNA based variant analysis32 FFPE samples for DNA-only or RNA only based variant analysis32 plasma samples for cfTNA based variant analysis
Product TypePrecision Assay GX
Quantity32 reactions
Unit SizeEach
Contents & Storage
Contains:
• 8 paired tubes of Oncomine Precision Panel GX
• 8 Strips of Ion Torrent Genexus Strip 1
• 8 Strips of Ion Torrent Genexus Strip 2 - ASHD

Store Oncomine Precision Panel at -10°C to -30°C.
Store Ion Torrent Genexus Strip 1 at 2°C to 8°C.
Store Ion Torrent Genexus Strip 2 - ASHD at -10°C to -30°C.

Frequently asked questions (FAQs)

How many samples of Oncomine Precision Assay GX can I run on each lane of the GX5 Chip?

The capacity of the GX5 Chip varies depending on the sample type:
- For plasma cfTNA samples, the workflow is configured to accommodate 1 sample per GX5 Chip lane (or 4 samples on a single GX5 Chip).
- For FFPE DNA+RNA samples, the workflow is configured to accommodate 4 samples per GX5 Chip lane.
- For FFPE DNA-only or RNA-only samples, the workflow is configured to accommodate 8 samples per GX5 Chip lane.

How many sequencing reactions can I perform with Oncomine Precision Assay GX (Cat. No. A44350)?

The maximum number of samples that can be analyzed per kit depends upon the type of analysis that you want to perform. Each kit provides the targeted pancancer panel and library reagents sufficient to perform up to 32 sequencing reactions on the Genexus Integrated Sequencer.

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

How much of each sample do I need for the Oncomine Precision Assay GX?

For solid tumor samples, the optimal input amount is 10 ng with validated input in the range of 5-15 ng. For liquid biopsy samples, the optimal input amount is 20 ng with validated input in the range of 5-40 ng.

For optimal results, load 20 µL of input with a concentration of ≥0.67 ng/µL for FFPE DNA and FFPE RNA samples and 20 µL of input with a concentration of ≥1.33 ng/µL for cfTNA samples. If the concentration of the sample is lower than optimal, use as much input as possible for each reaction.

What controls should I use with Oncomine Precision Assay GX?

Here are the various controls we recommend depending upon the starting material:

FFPE DNA samples
- Structural Multiplex Reference Standard (FFPE), Cat. No. HD789 (Horizon™)
- EGFR Gene-Specific Multiplex Reference Standard (FFPE) 5% AF, Cat. No. HD300 (Horizon™)
- KRAS Gene-Specific Multiplex Reference Standard (FFPE), Cat. No. HD301 (Horizon™)
- Seraseq® Lung & Brain CNV Mix, + 3 copies, Cat. No. 0710-0414 (SeraCare®)
- Seraseq® Breast CNV Mix, + 6 copies, Cat. No. 0710-0412 (SeraCare®)

FFPE RNA samples
- Seraseq® FFPE Tumor Fusion RNA v4 Reference Material, Cat. No. 0710-0496 (SeraCare®)
- Seraseq® FFPE NTRK Fusion RNA Reference Material, Cat. No. 0710-1031 (SeraCare®)

cfTNA samples
- Multiplex I cfDNA Reference Standard Set, Cat. No. HD780 (Horizon™)

Which sample types can I use with Oncomine Precision Assay GX?

Oncomine Precision Assay GX is compatible with solid tumor samples (FFPE DNA or FFPE RNA) as well as liquid biopsy samples (cfTNA).