Genexus Dx Integrated Sequencer Features

The smart design of the Ion Torrent Genexus Dx Integrated Sequencer is designed to minimize errors while maximizing your lab’s productivity.

Easy and efficient workflow

With a single touchpoint and as little as ten minutes of hands-on time, the Ion Torrent Genexus Dx Integrated Sequencer starts with purified nucleic acid and automates all remaining steps of the targeted next-generation sequencing (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.

Run planning

The user can select their desired sample(s) and assay(s) and use the intuitive setup wizard to create a run plan for the sequencer.

Sequencer setup

The onboard vision system verifies consumable installation in real-time using barcode and RFID detection, enabling proper setup in minutes.

Analysis and reporting

The user can view a report for each sample, sample-level quality control metrics, and a list of reagents that were used.

Designed for flexibility

The Genexus Dx Integrated Sequencer features dual-mode software enabling use of the instrument for both diagnostic (IVD) and research (assay development) applications. You even have the option to multiplex up to 32 library reactions per run 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. It is ready to help testing labs in the European Union (EU) and other countries deliver critical genomic information to patients and their healthcare team.

Summary of features

Intended Use: The 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.

 

CE-IVD system

Stringent performance characteristics to enable diagnostic use

 

Developed under design control principles, compliant with US Food & Drug Administration (FDA) Quality System Regulation (QSR) 21 CFR Part 820, and manufactured in facilities registered with FDA, ISO13485-certified, and 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 the Genexus Dx Integrated Sequencer.

 

Modulate run setup as samples come in with the flexibility of multiplexing up to 32 library reactions per run.

 

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

 

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
  • Helps prevent user error by allowing the Genexus Dx Integrated Sequencer’s onboard vision system to verify reagent placement and detect errors in real time

 

Automation

A Genexus Dx Integrated Sequencer run starts with purified nucleic acid and automates all remaining steps of the targeted NGS workflow.

 

Automated library prep, sequencing, and reporting all happen on one instrument with a set-up-and-go workflow that includes only a single touchpoint and as little as 10 minutes of hands-on time.

 

Speed

Rapidly go from nucleic acid to report in as little as 24 hours

For In Vitro Diagnostic Use.

Not available in all countries including the United States.