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End-to-end clinical NGS automation with the Genexus Dx System
The Ion Torrent Genexus Dx System is a clinical next-generation sequencing (NGS) platform for in vitro diagnostic (IVD) testing that delivers biomarker results in as little as 24 hours. This two-instrument system automates the main steps in the NGS workflow, including nucleic acid purification and quantification, library preparation, sequencing, bioinformatics analysis, and reporting.
The Genexus Dx Purification System and Genexus Dx Integrated Sequencer work together seamlessly with Genexus Dx Software, tracking sample information and results automatically through the process. This automated system reduces manual steps and facilitates generating quality data and quick reports, making in-house NGS testing accessible to more clinical laboratories regardless of experience and without the requirement to hire or train additional staff.
NGS has come a long way to be right where patients need it
The Genexus Dx System makes the NGS workflow fast and easy with walkaway automation, so clinical laboratories of all experience levels are able to bring the benefits of in-house next-generation sequencing to their patients. These advancements to the NGS workflow provide a new level of operational efficiency by reducing hands-on time and staff required for NGS testing, freeing up valuable time to focus on other priorities or to scale up the clinical testing done in the lab.
The Genexus Dx System NGS platform increases reproducibility of the NGS assays through easy automation. This platform provides long-term cost savings due to decreased labor requirements and combined service and support options. Clinical laboratories can now benefit from using IVD instruments engineered to work together, from the same trusted partner.
How does the Genexus Dx System work?
The Genexus Dx System consists of two instruments that are both controlled by the intuitive Genexus Dx Software for simplified sample input, run plan setup, data analysis, and report generation.
In the first step of this automated NGS workflow, the Genexus Dx Purification System quickly extracts, purifies, and quantifies nucleic acids with hands-free walkaway automation, eliminating manual pipetting steps from sample preparation. The Genexus Dx Integrated Sequencer next automates library prep, templating, sequencing, data analysis and reporting, delivering the only true end-to-end automated clinical NGS workflow specifically optimized to work together from a single company.
Genexus Dx Purification System
The Genexus Dx Purification System automates nucleic acid extraction, purification, and quantitation on a single platform for consistent and efficient NGS sample preparation. With a streamlined workflow and minimal hands-on time, you can go from patient specimen to NGS-ready nucleic acid in just minutes, ready to be loaded onto the Genexus Dx Integrated Sequencer.
Genexus Dx Integrated Sequencer
The Genexus Dx Integrated Sequencer automates NGS library preparation, sequencing, and analysis. When paired with the Genexus Dx Purification System, the two-instrument-plus-software system delivers a complete workflow solution. With workflow automation, sequencing performance, and automated data analysis and reporting, the Genexus Dx System brings NGS to any clinical lab without the need for extensive sequencing or bioinformatics expertise.
More about the Genexus Dx System workflow
The automated Genexus Dx System workflow reduces hands-on time to deliver clinical NGS test results quickly and easily, making rapid in-house NGS assays accessible to more molecular testing laboratories without the requirement for previous NGS experience or extensive training.
With just two manual touchpoints, one for setting up the automated sample purification run on the Genexus Dx Purification System and the other for setting up automated library preparation, sequencing, analysis, and reporting on the Genexus Dx Integrated Sequencer, and a total of 20 minutes of hands-on time for the entire workflow, NGS for biomarker testing of patient specimens has become as accessible as assays like PCR or IHC.
Figure 1: The Genexus Dx System is two instruments controlled by one intuitive software. The end-to-end workflow has just two manual touchpoints and a total of 20 minutes of hands-on time. Touchpoint 1 is setting up the Genexus Dx Purification System run, which includes automated nucleic acid extraction, purification, and quantification. Touchpoint 2 involves transferring the nucleic acid to a sample plate and setting up the Genexus Dx Integrated Sequencer run, which includes automated NGS library preparation, templating, sequencing, analysis, and reporting.
Related solutions and assays
The Genexus Dx System is used by clinical molecular testing labs and clinical researchers to perform NGS biomarker tests for their patient samples. The Oncomine Dx Express Test used with the Genexus Dx System provides a complete end-to-end IVD NGS testing workflow, from patient specimen to clinical report. The time to complete the workflow is comparable to other molecular testing methods such as PCR and IHC, yet provides more complete genomic profiling.
Oncology research solutions in Assay Development mode
Multiple additional research use only (RUO) Oncomine assays are also available for the Genexus Dx Integrated Sequencer in Assay Development mode to assay key biomarkers found in multiple cancers.
Oncomine assays are available for a range of clinical research applications, including:
- Genomic profiling
- Liquid biopsies
- Hematological malignancies
- Immuno-oncology
Design your own panels
In Assay Development mode, the Genexus Dx System supports development of customized targeted NGS panels with custom AmpliSeq products, allowing you to create the exact assay that you need.
The Ion AmpliSeq Designer helps you create custom assays in any application area, with any reference genome, with minimal time and effort. This free and easy-to-use web tool leads you through the steps and choices to build custom primer panels.
Featured Genexus Dx System assays and consumables
Intended Use: The Genexus Dx Purification System is a sample preparation instrument which automates nucleic acid extraction, purification, and quantification of DNA and RNA from FFPE tissue sections for use in next-generation sequencing applications. The system uses MagMAX magnetic bead-based technology to perform nucleic acid extraction. Purified nucleic acid is quantified using the onboard Qubit fluorometer, which uses fluorescence to measure nucleic acid.
Abbreviated Intended Use: The Oncomine Dx Express Test is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing (NGS) technology, the Ion Torrent Genexus Dx System to detect deletions, insertions, substitutions and copy number gain present in 42 genes and fusions in 18 genes from DNA and RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples. Oncomine Dx Express Test also detects deletions, insertions, substitutions in 42 genes and fusions in 7 genes from cfTNA extracted from plasma samples. The Oncomine Dx Express Test is intended to provide clinically relevant tumor mutation profiling information to be used by qualified health care professionals in accordance with professional guidelines as an aid in therapy management of cancer patients with solid malignant neoplasms using FFPE samples and as an aid in therapy management of cancer patients with non-small cell lung cancer using plasma samples. It is not conclusive or prescriptive for labeled use of any specific therapeutic product.
The Genexus Dx Purification System and Genexus Dx Integrated Sequencer: For In Vitro Diagnostic Use. CE-IVD according to IVDR. Not available in all countries including the United States.
Oncomine Dx Express Test: For In Vitro Diagnostic Use. CE-IVD according to IVDD. Not available in all countries including the United States.