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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”.
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.
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).
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 10 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
For Research Use Only. Not for use in diagnostic procedures.
*Scott JA, et al. Compromised Outcomes in Stage IV Non-Small-Cell Lung Cancer With Actionable Mutations Initially Treated Without Tyrosine Kinase Inhibitors: A Retrospective Analysis of Real-World Data. JCO Oncol Pract. 2024 Jan;20(1):145-153.
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