Overview
Features
Assays
Services
Resources


Overview

Introducing the Genexus Dx Integrated Sequencer

Designed to make next-generation sequencing (NGS) accessible to clinical laboratories with all levels of sequencing expertise, the Ion Torrent Genexus Dx Integrated Sequencer delivers an effortless user experience while enabling regulatory compliance.

Easy and efficient workflow

With a single touchpoint and ten-minutes of hands-on time, the Genexus Dx Integrated Sequencer starts with purified nucleic acid and automates all remaining steps of the targeted NGS workflow, including cDNA synthesis and library preparation, template preparation, sequencing, data analysis, and variant reporting. The result is an efficient workflow that is easily implemented in a variety of clinical lab settings.

 

Robust and flexible design

The Genexus Dx Integrated Sequencer features dual-mode software enabling use of the instrument for both diagnostic and research applications. You even have the option to multiplex up to 32 library reactions per run (in increments of four) to maximize throughput, or to analyze individual samples as they come in, to maximize turnaround time.

Engineered to enable NGS in clinical labs

The Genexus Dx Integrated Sequencer enhances your laboratory's productivity and innovation, whether you are running diagnostic tests or performing clinical research.

 

The Genexus Dx Integrated Sequencer is ready to help testing labs in the European Union (EU) and other countries deliver critical genomic information to patients and their healthcare team.


Features

Intended Use: The Ion Torrent Genexus Dx Integrated Sequencer is an in vitro diagnostic (IVD) medical device intended to be used by trained personnel in a professional laboratory environment for automated, qualitative targeted sequencing of human DNA or RNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue samples or plasma samples. The Ion Torrent Genexus Dx System consists of the Ion Torrent Genexus Dx Integrated Sequencer, and the Ion Torrent Genexus Dx Software.

CE-IVD system
  • Stringent performance characteristics to enable diagnostic use
  • Developed under design control principles, manufactured in facilities regulated by FDA, ISO13485 certified, manufactured under Current Good Manufacturing Practices (cGMPs)
Flexibility
  • Perform IVD assays and conduct clinical research on the same instrument
  • All research assays and applications performed on the RUO Genexus Integrated Sequencer can be performed on Genexus Dx Integrated Sequencer
  • Upgrade RUO systems to IVD with a simple software and label update, no hardware changes
  • Modulate run setup as samples come in with the flexibility of multiplexing up to 32 library reactions per run in increments of four
Speed
  • Rapidly go from nucleic acid to report in as little as 24 hours
Automation
  • Library prep, sequencing, and reporting all happen on one instrument with a set-up-and-go workflow
  • Flexibility to accommodate small sample batches—on-instrument reagent and chip stability supports sample intake variability
  • With a single touchpoint that includes ten-minutes of hands-on time, the Genexus Dx Integrated Sequencer starts with purified nucleic acid and automates all remaining steps of the targeted NGS workflow
Design
  • Innovative multi-lane chip—simultaneously process up to four compatible assays in a single run
  • Reduce NGS operating costs with simplified setup using pre-filled reagents
  • Prevent user error by allowing the Genexus Dx Integrated Sequencer’s onboard vision system to verify reagent placement and detect errors in real time
Software
  • Software partitioned for IVD and RUO applications
  • Enables 21 CFR Part 11 compliance
  • Find meaning in generated data by identifying markers based on relevant evidence
  • Even novice users with limited bioinformatics experience can generate analysis

Genexus Dx Integrated Sequencer workflow

The hands-off, automated workflow from nucleic acid to variant report begins with run planning using Genexus Dx Software. During run planning the user can select their desired sample(s) and assay(s) and use the setup wizard to create a run plan for the sequencer. During sequencer setup, which takes ten minutes of hands-on time, the onboard vision system verifies consumable installation in real-time using barcode and RFID detection, ensuring proper setup before the run begins. After the run is completed, the user can view a report for each sample, sample-level quality control metrics, and a list of reagents that were used.

Consumables

Consumables for the Genexus Dx Integrated Sequencer are designed to reduce labor and errors. Ready-to-load kits, chips, and packs simplify NGS setup and process. A barcode system works with on-board cameras to prevent setup and experimental errors.

Key benefits:

  • Fast setup—pre-filled, barcoded plates help reduce hands-on time
  • Established technology—proven Ion Torrent products enable consistent results throughout the workflow
  • Minimize quantity-not-sufficient (QNS) failures—ability to run smaller tissue volumes
  • Extract nucleic acids from sources including:
    • Lysate from FFPE tissue
    • Plasma


Assays

Genomic profiling in precision oncology is transforming patient care, but long waiting periods for biomarker results can delay treatment decisions. The Oncomine Dx Express Test, a CE-IVD solution, enables laboratories to deliver clinically relevant genomic profiles in as little as 24 hours, to aid clinicians in making timely therapy decisions.


Service and support



Equipment shouldn’t slow you down. In addition to hands-on training at your lab, we offer on-site service plans, self-paced online courses, remote support options, and consulting services to help you get the most from your product.

 

 

 

Installation
  • Conducted on-site by a professionally trained Field Service Engineer
Instrument-driven support
  • Genexus Software enables Customer Support Archives (CSA)
  • CSA generates technical support request
  • Easy sharing of log and run files
  • Instrument connectivity required
Smart remote support
  • Immersive collaboration tool for faster troubleshooting and resolution
  • Augmented reality technology with real-time video and audio collaboration
  • Advanced remote desktop support tool
  • Instrument connectivity not required
Field service
  • Superior support from experienced field service specialists
  • 12-month warranty
  • AB Assurance service contract available
  • Additional service package offerings to include Priority Technical Support, 24-hour response, and on-site service plans available
Training
  • SmartStart Orientation includes hands-on training and an introduction to data analysis

Get more information on service plans, qualification services, and training specific to your region, at thermofisher.com/instrumentservices.


Resources

For In Vitro Diagnostic Use. Not available in all countries including the United States.

Style Sheet for Global Design System