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Oncomine Precision Assay on the Genexus System

Rapid NGS means results in
as little as 24 hours

The number of molecular biomarkers relevant for precision oncology research is rapidly growing across solid tumor types and in many cases single gene testing methods do not yield desired results in time or for limited number of biomarkers only.

 

Therefore, NGS has become a technology of choice in precision oncology research for genomic profiling of  FFPE tissue or liquid biopsy tumor samples*.

Implement NGS in your research laboratory without the complexity, high labor costs, or expertise

An automated end-to-end NGS solution

The Oncomine Precision Assay is part of an end-to-end solution with a workflow consisting of only two instruments run by one intuitive software interface and also includes a complete bioinformatics pipeline and reporting solution. This means you do not need additional expert resources in your lab and will only have to introduce a small number of new SOPs.

Minimal hands-on time

The whole workflow is automated with only two touch points and as little as 20 minutes of hands on time. This means you will not need much additional technicians’ time.

Everything you need with one supplier

Everything from instruments, software, reagents and consumables, as well as service and ongoing support, comes from one supplier: Thermo Fisher Scientific, which aims to make your implementation, as well as day-to-day running of this workflow, as  simple as possible.

Interview: The "Impossibly" Easy NGS

Read a short interview with one of the users, Dr. Lara Navarro, Head Biologist in the Anatomical Pathology Department of the General University Hospital of Valencia, Spain, who shares her experience with this solution, saying they “didn’t think it was possible to implement NGS in their lab and realized that this workflow is one of the simplest they have here in the laboratory”.

Dr. Lara Navarro

Head Biologist in the Anatomical Pathology Department

General University Hospital of Valencia
Spain

Improve NGS lab efficiency with shorter turnaround times and reduce QNS (quantity not sufficient)

NGS results in as little as 24 hours

The Oncomine Precision Assay delivers results in as little as 24 hours, which will enable you to report those samples faster than ever before and combine NGS results with other technologies results, like PDL1 by IHC, in one complete relevant biomarker report.

*Timing varies by number of samples and run

Minimal sample required

The required sample input is only 10 ng of DNA or RNA, meaning you can analyze and deliver a report even on small samples, including fine needle aspirates (FNA).

 

Liquid biopsy analysis

If no tissue available or for monitoring purposes, the Oncomine Precision Assay can analyse also liquid biopsy samples from plasma or other body fluids.

 

Analyze DNA and RNA variants

With Oncomine Precision Assay you can analyze variants from one sample in one test.

Presentation: Simultaneous DNA and RNA variant testing by Oncomine Precision Assay 

Watch the presentation by assay user Annarita Destro, who shares her experience with the assay and discusses the benefits of simultaneous analysis of DNA and RNA variants. She summarizes that, in her laboratory, this simultaneous analysis leads to savings in samples and resources, improved result accuracy, and shortened turnaround time (TAT).

Annarita Destro PhD

Head of Molecular Pathology Department

Humanitas Research Hospital
Italy

Performance of Oncomine Precision Assay on FFPE controls

Sample Range Variant type # of variants 
per sample		 # of sample 
replicates		 Sensitivity PPV
Internal FFPE control 4.8% + 2.3% SD AF* SNV 67 32 99.6% 99.6%
INDEL 4 32 100% 100%
Horizon structural multiplex FFPE reference standard  3.5% to 17% AF* SNV/INDEL 15 32 100% 100%
4.5 copies CNV 1 32 93.8% 100%
SeraSeq FFPE tumor fusion RNA reference material 10–258 copies FUSION 13 32 98.6% 99.3%
SeraSeq FFPE NTRK fusion RNA reference material 94–377 copies FUSION 15 32 99.2% 99.2%
SeraSeq lung & brain CNV mix + 3 copies (5 copies) CNV 2 32 100% 100%
SeraSeq breast CNV mix + 3 copies (5 copies) CNV 2 32 100% 100%

Note: Testing was performed at multiple internal R&D laboratories as part of product verification testing. Samples were run at different plexy levels. Additional verification and validation testing will be performed using the Oncomine Precision Assay and FFPE controls; therefore final performance values can change.
* Indicates observed allele frequency using Oncomine Precision Assay on Genexus System.

 

Performance of Oncomine Precision Assay on liquid biopsy controls

Range Variant type # of variants 
per sample		 # of sample 
replicates		 Sensitivity PPV
0.33% + 0.17% SD AF* SNV 67 32 89.2% 100%
INDEL 4 32 100% 100%
1.16X fold change CNV 1 32 100% 100%
1% tri-fusion and MET exon 14 skip in total RNA FUSION 1 32 97.7% 96.4%

Note: Testing was performed at multiple internal R&D laboratories as part of product verification testing. Samples were run at different plexy levels. Additional verification andvalidation testing will be performed using the Oncomine Precision Assay and FFPE controls; therefore final performance values can change.
* Indicates observed allele frequency using Oncomine Precision Assay on Genexus System.

Do you want to implement liquid biopsy testing? 

With the Oncomine Precision Assay you can do that without introducing a new assay and workflow in your lab. It will enable you to analyze the same biomarkers from liquid  and FFPE tissue biopsy samples.

Oncomine Precision Assay gene list

The Oncomine Precision Assay on the Genexus System is a next-generation solution for genomic profiling that’s accessible for laboratories of all sizes. Now labs can employ a hands-off workflow to detect key biomarkers such as EGFR, ALK, BRAF, ROS1, NTRK, RET, or ERBB2 from formalin-fixed paraffin-embedded (FFPE) tissue or liquid biopsy specimens in one day.

 

  • Mutation, CNV, and fusion variant types across 50 key genes such as EGFR, ALK, BRAF, ROS1, RET, KRAS, PIK3CA, and ERBB2, among others
  • One-day, hands-free workflow with only two touch points and 20 minutes of hands-on time
  • Only 10 ng of DNA/RNA required, allowing for more samples to be tested
  • Compatible with FFPE tissue as well as liquid biopsy samples
DNA hotspots CNVs Inter-genetic fusions Intra-genetic fusions
AKT1 CHEK2 FGFR3 KIT NTRK3 ALK FGFR1 ALK NTRK1 AR
AKT2 CTNNB1 FGFR4 KRAS PDGFRA AR FGFR2 BRAF NTRK2 EGFR
AKT3 EGFR FLT3 MAP2K1 PIK3CA CD274 FGFR3 ESR1 NTRK3 MET
ALK ERBB2 GNA11 MAP2K2 PTEN CDKN2A KRAS FGFR1 NUTM1  
AR ERBB3 GNAQ MET RAF1 EGFR MET FGFR2 RET  
ARAF ERBB4 GNAS MTOR RET ERBB2 PIK3CA FGFR3 ROS1  
BRAF ESR1 HRAS NRAS ROS1 ERBB3 PTEN MET RSPO2  
CDK4 FGFR1 IDH1 NTRK1 SMO     NRG1 RSPO3  
CDKN2A FGFR2 IDH2 NTRK2 TP53          

The Genexus System automated NGS workflow

2 instruments | 1 software | 2 touchpoints


TheGenexus System is a two-instrument next-generation sequencing (NGS) platform that automates all essential stages of the NGS workflow. This includes sample purification and quantification, library preparation, sequencing, bioinformatics analysis, and reporting.

Ordering information

Catalog # Name Size Price Qty
A46291 Oncomine™ Precision Assay GX Each
7,410.00

Oncomine Precision Assay frequently asked questions

The Oncomine Precision Assay is a targeted NGS panel designed to detect variants across multiple cancer types relevant in clinical oncology research. It uses a single, streamlined workflow that reduces complexity and hands-on time compared to traditional multi-assay approaches and other NGS workflows. The assay supports FFPE tissue and liquid biopsy sample analysis, enabling a wide range of research applications.

The assay detects a broad range of variant types, including:

  • Single nucleotide variants (SNVs)

  • Insertions and deletions (indels)

  • Gene fusions

  • Copy number variations (CNVs)

DNA hotspots CNVs Inter-genetic fusions Intra-genetic fusions
AKT1 CHEK2 FGFR3 KIT NTRK3 ALK FGFR1 ALK NTRK1 AR
AKT2 CTNNB1 FGFR4 KRAS PDGFRA AR FGFR2 BRAF NTRK2 EGFR
AKT3 EGFR FLT3 MAP2K1 PIK3CA CD274 FGFR3 ESR1 NTRK3 MET
ALK ERBB2 GNA11 MAP2K2 PTEN CDKN2A KRAS FGFR1 NUTM1  
AR ERBB3 GNAQ MET RAF1 EGFR MET FGFR2 RET  
ARAF ERBB4 GNAS MTOR RET ERBB2 PIK3CA FGFR3 ROS1  
BRAF ESR1 HRAS NRAS ROS1 ERBB3 PTEN MET RSPO2  
CDK4 FGFR1 IDH1 NTRK1 SMO     NRG1 RSPO3  
CDKN2A FGFR2 IDH2 NTRK2 TP53          

Using a simple two-instrument integrated workflow, labs can achieve:

  • As little as 24-hour sample-to-report time enabling labs to send timely biomarker reports

  • As little as 20 minutes of hands-on time from sample extraction to result, supporting consistent, reproducible performances across runs, potential handling error points reduction and improved lab efficiency

The assay is optimized for the following:

  • Formalin-fixed paraffin-embedded (FFPE) tissue samples

  • Plasma (cell-free DNA / liquid biopsy)

The assay requires only:

  • 10 ng DNA/RNA for FFPE

  • 10 ng cfDNA for liquid biopsy

This low-input requirement supports reliable analysis even when sample availability is limited.

Ready to speak with a Thermo Fisher Scientific representative?

If you are interested in learning more about Oncomine comprehensive genomic profiling (CGP) solutions for solid tumors and see a demo, please request contact from a local representative.

 

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