Genexus™ Dx Integrated Sequencer

• 정보: 본 제품은 '체외진단의료기기'이며, '사용상의 주의사항'과 '사용방법'을 잘 읽고 사용하십시오.
• 의료기기 광고심의필: 32023-I10-35-2752 (유효기간 26.10.06)
• 차세대염기서얼분석장치 / 유전자 라이브러리 기술, 전위차 검출 기술 등으로 넓은 범위의 유전자 염기서열을 분석하여 진단에 사용하는 차세대염기서열분석장치와 형광검출기가 없이 질병진단을 위해 임상 검체 중 세포 또는 감염체의 핵산(DNA 또는 RNA)을 증폭하는 일반유전자증폭장치가 조합된 조합체외진단의료기기

The Ion Torrent Genexus Dx Integrated Sequencer is an in vitro diagnostic (IVD) next-generation sequencing (NGS) platform that delivers the speed, scalability, and simplicity of the Genexus Integrated Sequencer, while empowering clinical laboratories with the flexibility to run IVD assays and assay development for clinical research on a single platform.

The Genexus Dx Integrated Sequencer offers:

• Speed—complete nucleic acid to report workflows in a single day with a single touchpoint, and 10 minutes of total hands-on time
• Simplicity—automate library prep, sequencing, analysis and variant calling all on one instrument using pre-filled reagents
• Scalability—modular consumables support multiplexing up to 32 library reactions per run across one to four lanes of the GX5 Dx chip
• Flexibility—use the Genexus Dx Software to run IVD assays and assay development for clinical research
• Confidence—prevent user error by providing real-time feedback on consumable placement using the onboard vision system

Proven technology and performance

The Genexus Dx System is built on proven Ion Torrent 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, consumables and integrated software were developed under stringent design control with a complete design history file, and are manufactured under GMP at ISO 13485 facilities to help ensure performance and quality standards are met.

Speed, simplicity, and scalability

The Genexus Dx Integrated Sequencer completes all steps of the nucleic acid-to-report workflow in a single day. With a single touchpoint and 10 minutes of hands-on time, the Genexus Dx Integrated Sequencer automates NGS library preparation (including cDNA synthesis), template preparation, sequencing, primary data analysis, and variant reporting for DNA, RNA, and cfTNA applications. Sequencing on the Genexus Dx Integrated Sequencer is enabled with modular consumables that scale to allow up to 32 library reactions per run in increments of four, and a four-lane semiconductor chip: the GX5 Dx Chip. Each of the four lanes of the GX5 Dx Chip supports the output of 12–15 million reads, and they can be used individually or all at once depending on throughput needs.

Integrated secure software to ensure high integrity results

Genexus Dx Software streamlines the NGS workflow by integrating all steps from run planning to variant reporting into a single software ecosystem while providing full data traceability and auditable run analysis – required for 21CFR Part 11 compliance. Genexus Dx Software helps ensure a high level of results integrity by containerizing assay design files, algorithms, and UI features into a self-sufficient package. In assay development mode, Genexus Dx Software provides users the flexibility of optimizing a new assay while continuing to run an already implemented assay on a single Genexus Dx Integrated Sequencer, eliminating the need for multiple instruments in a testing environment.

Package description

The package includes the Ion Torrent Genexus Dx Integrated Sequencer, AB Assurance Dx Service Plan, IQOQPQ, SmartSmart Orientation, and Bioinformatics Support Plan.

AB Assurance Dx Service Plan

The AB Assurance Dx Service Plan is exclusively for Dx instruments and designed to maintain instrument performance to help ensure availability of critical instrument systems in your workflow. The AB Assurance Dx Service Plan will help keep your laboratory operations running smoothly with planned maintenance, qualification services, proactive instrument monitoring (where available), and—should your instruments require service—a timely response. This service plan is ideal for locations like clinical and IVD laboratories that depend on their Dx instruments and need to reduce the risk of production downtime. Service and instrument hardware qualification documentation are provided as supporting proof of instrument performance and maintenance history for customer Quality Management Systems (QMS).

Qualification services help ensure regulatory compliance

Installation, operational, and performance qualification (IQOQPQ) services are included in this package. IQOQ documents that the instrument has been installed and operates according to manufacturer's specifications. PQ documents that the system can perform effectively and reproducibly within performance specifications. Qualification services are recommended at installation, after moving the instrument, upgrading software or hardware, planned maintenance, or critical repairs.

Get up and running fast with SmartStart Orientation

• Get up and running quickly
• Get connected to your local network and cloud
• Choose appropriate reagents and consumables to meet your needs

Content will vary depending on your level of knowledge and experience.

Bioinformatics Support Plan

Our team of computational biologists can help bring you confidence in your genomics pipeline. Beginning with an in-person assessment and a tailored training program to build your bioinformatics foundation, this plan helps optimize your lab's proficiency with the Ion Torrent family of data tools.

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 (not available in the US) samples.

Class II medical device listed with the US FDA.

Fulfills IVD Regulation (EU) 2017/746.

For In Vitro Diagnostics use in the US and select countries in Europe, Middle East, Africa, Asia, and Latin America; for availability in your country, contact your Thermo Fisher Representative.

*cfTNA not available in the U.S.