Next-generation sequencing (NGS) is an indispensable tool, enabling the simultaneous interrogation of hundreds of genes and biomarkers to generate accurate and affordable genetic information. The combined functionality of the Ion PGM™ Dx System enables us to serve the broader clinical molecular diagnostics community as well as clinical researchers by offering an In Vitro Diagnostic (IVD) mode for IVD applications and an Assay Development mode for Research Use Only (RUO) applications. The Ion PGM Dx System* delivers the speed and simplicity of Ion Torrent™

technology, and provides a complete IVD workfl ow of instruments, consumables, reagents, and software—all developed under design control.

Ion PGM™ Dx Software Pack (5.6 and later) offers expanded system utility with diagnostic and assay development modules.

Ion PGM Dx SystemEmpowers your clinical laboratory with next-generation sequencing and combined functions for expanded system utility

Ion PGM Dx System —using Torrent Suite™ Dx Software (IVD mode), supports the following targeted applications: • Targeted Analysis using DNA derived from whole blood

• Somatic analysis using DNA or RNA derived from formalin-fi xed, paraffi n embedded (FFPE) samples

IVD

Ordering information

Product Cat. No.

Ion PGM Dx Instrument System A25511 Includes the components below:

• Ion PGM Dx Sequencer• Ion OneTouch Dx Instrument• Ion OneTouch ES Dx Instrument• Ion PGM Dx Chip Minifuge• Torrent Suite Dx Software v5.6 or later• Ion PGM Dx System Installation & Training Kit• Wireless Handheld 2D Barcode Scanner• DynaMag Dx Kit-Tube & Plate

Ion PGM Dx Instrument System consumables A25512 Includes the components below:

• Ion PGM Dx Library Kit• Ion OneTouch Dx Template Kit• Ion PGM Dx Sequencing Kit• Ion 318 Dx Chip Kit

© 2016–2017 Thermo Fisher Scientifi c Inc. All rights reserved. All trademarks are the property of Thermo Fisher Scientifi c and its subsidiaries unless otherwise specifi ed. COL31815 0717

Find out more at thermofi sher.com/pgm-dx

* The Ion PGM Dx System is for In Vitro Diagnostic Use. The Ion PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing. Available in the US and other selected countries.

† The Veriti Dx Thermal Cycler is required equipment that is purchased separately.

Constructlibrary

Preparetemplate

Runsequence

Analyzedata

Ion OneTouch™ Dx andIon OneTouch™ ES Dx

Systems

Ion PGM™ DxSystem

Torrent Suite™ Dx Software

Ion PGM™ Dxlibrary kit

Applied Biosystems™

Veriti™ Dx Thermal Cycler†

Ion OneTouch™ DxTemplate Kit

Ion PGM™ DxSequencing Kit and Ion 318™ Dx Chip Kit

Equipment

Reagents

Key benefi ts of the Ion PGM Dx System • Developed under design control

and in accordance with ISO 13485 requirements, offering a complete NGS system of instruments, consumables, reagents, and software, with a complete design history fi le

• Complete end-to-end, fully validated IVD workfl ow from sample-to-results in 4 days

• Enables results using 10 ng of DNA or RNA from FFPE, or DNA from whole blood samples

• Optimized data analysis workfl ows developed for targeted DNA, RNA, and cDNA sequencing, enabling users to create protocols that are run in a locked workfl ow environment, from library construction to variant calling and reporting

• Includes in-run controls for automatic assessment of run success

• Helps enable 21 CFR Part 11 compliance, offering role-based workfl ows, sample and reagent tracking, QC metrics, and an audit trail

• Compatible with many laboratory information management systems, providing XML input and manager-controlled data output

Bring the power of Ion Torrent NGS into your diagnostics laboratory