The Ion PGM™ Dx System is a reliable and robust in vitro diagnostic (IVD) next-generation sequencing (NGS) platform that is designed to deliver the proven performance and simplicity of the Ion Torrent™ PGM system, while empowering clinical laboratories with the flexibility to develop molecular diagnostic assays to help meet their evolving needs.

The Ion PGM™ Dx System:
• Offers a complete, simple, and cost-effective IVD NGS instrument system solution
• Enables highly reproducible and accurate genetic variant analysis with as little as 10 ng of input DNA
• Provides rapid turnaround time from sample to variant analysis in <2 days
• Enables molecular diagnostic assay developers the flexibility to publish protocols in a locked workflow environment
• Helps increase laboratory efficiency with integrated software that supports sample and reagent tracking, auditing, and traceability compliance
• Supports role-based workflows to help ensure a higher level of results integrity

Proven technology and performance
The Ion PGM™ Dx System is built on proven Ion Torrent™ Post-Light™ Ion Semiconductor Sequencing technology that is well-established and adopted globally in life sciences and clinical research. With this system, the technology has been refined and designed specifically to help meet the increasing needs of the diagnostic laboratory environment. The system provides a comprehensive set of instruments, reagents & consumables, and integrated software developed under stringent design control with a complete design history file, and manufactured under GMP to help ensure performance and quality standards are met.

Results generated using the Ion PGM™ Dx System proved highly reproducible in a validation study across multiple sites, operators, and reagent kits. Overall system performance was excellent with an average SNV sensitivity of >99.5%. The system was validated using challenging germline variants, with library generation based on proven Ion AmpliSeq™ technology, enabling accurate and reliable genetic analysis even with input DNA amounts as low as 10 ng.

Flexibility & scalability
The Ion PGM™ Dx platform empowers clinical laboratories with the flexibility and scalability to reliably develop and implement their own molecular diagnostic assays using the Ion PGM™ Dx System and GMP manufactured reagent sets combined with their choice of targeted analyte specific reagents. Leveraging Ion Ampliseq™ ultrahigh-multiplex PCR targeted library generation technology, the system enables assay developers to define and customize their assay primer sets of any panel size, and to validate, lock, and publish protocols in a role-based workflow environment for implementation into routine use.

Simple & efficient workflow to help maximize throughput
The Ion PGM™ Dx System delivers the speed and simplicity of the Ion Torrent™ platform, combined with key workflow advantages designed specifically for regulated laboratory environments and in vitro diagnostic applications. A simplified instrument and assay workflow, as well as intuitive software, further automate the testing turnaround time, providing rapid sample-to-variant analysis results in as little as 2 days. Additionally, the validated workflow enables multiplexing of up to 16 samples within a single sequencing run, making it a cost-effective and flexible approach.

Integrated secure software helps ensure high integrity results
Ion PGM™ Dx Torrent Suite™ software is an integrated software system that manages and tracks the entire run process from sample definition to variant analysis, providing full data traceability and auditable run analysis—a necessary part of 21CFR Part 11 compliance. With a user-friendly intuitive software interface, multi-tier role-based workflows, and a suite of parameter controls, the software aids clinical laboratories in maintaining high performance standards and helps ensure a higher level of results integrity.

The unique capabilities and features of the Ion PGM™ Dx System designed specifically for regulated laboratory environments make it a suitable next-generation sequencing platform-of-choice for nearly every clinical diagnostic laboratory.

Services and support
Service and support plans—comprehensive plans to maximize instrument performance and ensure availability of critical systems
Qualification services—document and ensure instrument is installed, operating, and performing to manufacturer’s specifications
Training—courses for experimental design, data analysis, troubleshooting, applications, and instrument operation
Bioinformatics—tailored support for NGS informatics execution, software use, data analysis, and downstream applications
DataSafe Solution—storage and back-up strategy, design, hardware, and support for all lab data

Intended use
The Ion PGM™ Dx Instrument System is composed of a sequencing instrument that measures the hydrogen ions that are generated during the incorporation of nucleotides in the DNA sequencing reaction and the ancillary instrumentation necessary for sample processing. This instrument system is used in conjunction with the instrument-specific Ion PGM™ Dx Library Kit, Ion OneTouch™ Dx Template Kit, Ion PGM™ Dx Sequencing Kit, and Ion 318™ Dx Chip Kit, and data analysis software. The Ion PGM™ Dx Instrument System is intended for targeted sequencing of human genomic DNA from peripheral whole-blood samples. The Ion PGM™ Dx Instrument System is not intended for whole genome or de novo sequencing.