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Manufactured at an FDA-registered and ISO 13485–certified facility and leveraging trusted MagMAX sample preparation and Qubit nucleic acid quantification technologies, the Ion Torrent Genexus Dx Purification System is an in vitro diagnostic (IVD) instrument that automates high-quality nucleic acid extraction, purification, and quantification for clinical next-generation sequencing (NGS) to give you total confidence through consistent results.
The Genexus Dx Purification System automates nucleic acid purification for NGS to reduce user processing errors and increases the reproducibility of your results by requiring just one touchpoint with 10 minutes of hands-on time. In as few as two hours, the system provides NGS-ready purified and quantified nucleic acid samples that are ready to be loaded directly onto the Genexus Dx Integrated Sequencer for downstream NGS applications. The Genexus Dx Purification System can be used to process patient FFPE specimens and other sample types to enable NGS assays for rapid biomarker testing.
The Genexus Dx Purification System’s validated and verified automation protocols allow you to stay focused on other activities in the clinical lab while the instrument’s labor-saving workflow reliably prepares your nucleic acid samples for NGS.
Figure 1. The simple, streamlined, and automated Genexus Dx Purification System workflow
In addition to the automated NGS sample preparation workflow, the Genexus Dx Purification System also utilizes pre-packaged, plug-and-play consumables that are designed to save time, simplify run setup, and reduce user errors.
Simply load the prefilled barcoded plates into the instrument and you’re ready to go.
Figure 2. Pre-packaged and barcoded reagents and consumables for the Genexus Dx Purification System
On-board cameras read the barcoded plates and detect incorrectly loaded consumables. If any consumables are loaded incorrectly or are expired, you’ll get an error notification that prevents the run from starting until all the reagents are correctly placed.
Figure 3. On-board cameras deliver an error message if they detect incorrectly loaded consumables
The Genexus Dx Purification System has an IVD kit to purify and quantify DNA and RNA from the same patient FFPE sample in a single automated run. The instrument is also compatible with additional research use only (RUO) kits in Assay Development mode to perform DNA, RNA, and cell-free total nucleic acid (cfTNA) purification from multiple specimen types including plasma, whole blood, PBLs, and lysate from FFPE tissue, fresh-frozen tissue, and bone marrow.
When paired with the Genexus Dx Integrated Sequencer, the Genexus Dx Purification System enables automated NGS from clinical oncology specimens for multiple biomarker types, including fusions, insertion/deletions (indels), single nucleotide variants (SNVs), and copy number variations (CNVs).
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.
For In Vitro Diagnostic Use. CE-IVD according to IVDR. Not available in all countries including the United States.