The new EU legislation for in vitro diagnostic (IVD) medical devices, In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746, will be applied on May 26, 2022 after the five-year transition period has ended. Thermo Fisher Scientific is committed to supporting clinical laboratories across the EU in preparation for the transition to this new regulation.
To this effect, we have been working diligently to ensure that the Ion Torrent Genexus System will be compliant with the regulations and bear the CE mark in early 2022. This system is currently the only next-generation sequencing (NGS) system providing end-to-end automation with results available in as little as 24 hours.
If you would like to be contacted by one of our sales representatives to receive information about, a demo of, or a quote for the Genexus System IVD or to be updated on its availability, please subscribe for future communications.
Your questions, answered
Currently, only the Genexus System with research use only (RUO) approval is commercially available. This system is manufactured at ISO 13485-certified facilities and will be upgrade-able to IVD in 2022 (when available). Subscribe to discuss the option of buying now and upgrading later with a sales representative and to receive updates on availability.
Updating to IVD requires only software and labeling upgrades carried out by a Thermo Fisher Field Service Engineer (FSE). There are no hardware changes needed. Subscribe to let your local sales representative know that you are interested in the upgrade and keep informed on availability. The cost is currently estimated to be 30,000 EUR, but flexible financing options and promotions will be available to support these upgrades.
We estimate that the IVD version of the Oncomine Precision Assay GX (Oncomine Dx Express Test, ODxET) will be commercially available in April 2022 time-frame. We are working on the clinical validation and delivery of this 50-gene assay in compliance with CE mark requirements.
Thermo Fisher Scientific is committed to delivering additional validated assays compatible with the Genexus System IVD. These applications include, but are not limited to, comprehensive genomic profiling, and hemato-oncology.
Further details regarding these assays will be coming soon. Subscribe to receive updates on availability.
Yes, the system will have two software modes:
- IVD mode for the IVD tests to enable compliance
- Assay Development mode for research testing enabling the use of RUO reagents and assays as well as lab eeveloped tests (LDTs)
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Additional resources to learn about and prepare for your IVDR transition
Lab Compliance Connect Virtual Event
January 25, 2022
Part 1: IVDR: Impact and Opportunities for a Molecular Pathology Laboratory
In this webinar, key stakeholders will discuss the value of the new regulation, its impact for molecular pathology laboratories, med-tech, biotech and pharma industries, and its benefits for the future of precision medicine.
- Explain the differences between IVDD and IVDR and the benefits of the new regulation
- Identify the IVDR challenges and bottlenecks that industries are facing and ways to mitigate them
- Discuss IVDR impact on laboratory-developed tests and implications for a molecular pathology laboratory and patients
Anna Sadio, Manager of Regulatory Affairs, Thermo Fisher Scientific
Johanna Koolen, Sr. Regulatory Analyst, Thermo Fisher Scientific
Part 2: Analytical Validation and Performance Verification, key components for IVDR compliance
Laboratory Developed Tests (LDTs) are in scope of the IVDR for cases where commercially available IVD tests are not available whilst the clinical need exists.
In this virtual event, validation project managers will share their experiences and insights into the analytical validation (AV) journey. We will also explore the ISO15189 validation guideline and the need for the Analytical Validation from a regulatory perspective.
- Identify reasons/requirements to complete an Analytical Validation
- Describe Thermo Fisher Scientific’s approach to consulting on an AV project
- Outline the Assay Performance Verification, how it ensures your workflow is optimized, and how it assists in determining readiness for a validation of a Laboratory Developed Test
Rafael Ramirez, Global Business Development Manager, Thermo Fisher Scientific