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Infectious Disease
Clarigene RUO
Clarigene CE-IVD
Clarigene SARS-CoV-2 CE-IVD
Clarigene™ Feature Notes
NIPT
IONA® Nx
For Clinical Laboratories
Overview
Workflow
Clinical Performance
Benefits of the IONA® Nx NIPT Workflow
Instruments
IONA® Software
Atlas Workflow Manager
MyNIPT®
Technical Support
Quality and Regulatory
Choose IONA® Nx NIPT Workflow
the IONA® test
For Clinical Laboratories
Overview
Technology
CE-IVD
Clinical Performance
Results
MyNIPT®
Application Support
FAQs
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Laboratory Customer Login
For Pregnant Women
Overview
What is NIPT?
How does it work?
Performance Characteristics
Who can have the IONA® Test
Results
Where can I get the IONA® test?
UK & Ireland Locations
Nordic Locations
Rest of World Locations
FAQs
For Healthcare Professionals
Overview
Background
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MyNIPT®
Who can have the IONA® Test
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Responsible Screening
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Resources
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Sage™ Prenatal Screen
For Clinical Laboratories
Overview
Technology
Clinical Performance
Results
Choose Sage™
Sage QS 32plex
For Pregnant Women
Advantages of the Sage™ prenatal screen
Overview
Who can have the Sage™ test
Results
For Healthcare Professionals
Overview
Background
Who can have the Sage™ test
Results
Clinical Performance
Contact Us
Reproductive Health
Cystic Fibrosis
Cystic Fibrosis Analysis
Choose CF-EU2
Male Infertility
Pregnancy Loss
Rapid Aneuploidy Analysis
Thrombosis Risk Panel
Precision Medicine
Elucigene DPYD
DPYD Overview
DPYD Testing Workflow
Clinical Performance
Choose Elucigene DPYD
Yourgene Flex™
Platforms
Yourgene® QS250
Yourgene® SP150

CE-IVD:

  • The IONA® Nx NIPT Workflow is a CE-marked in vitro diagnostic product which meets the requirements laid out in the European In Vitro Diagnostic Directive (98/79/EC). The IONA® Nx NIPT Workflow meets the stringent regulatory requirement for a non-invasive screening test and has been externally reviewed by a Notified Body. This is substantially more rigorous than a self-certification CE mark, in line with the IONA® Nx NIPT Workflow’s classification under Annex II list B of the Directive.
  • In addition, the IONA® Software for analysis has been built to stringent quality standards and has been developed with BS EN 62304 compliance. The IONA® Nx NIPT Workflow received its CE mark in June 2020. This ensures a high-quality robust, reproducible screening test with verification and clinical validation already performed to enable fast implementation with confidence.
  • Click here to access Yourgene's Quality Certifications.

Australia:

  • The IONA® Nx NIPT Workflow has also been approved by Australia’s Therapeutics Goods Association (‘TGA’) as a medical device Class 3 and the test is commercially available in Australia through our distributor, Southern Cross Diagnostics.

We are working hard to add further regulatory approvals in new regions that are covered by the Illumina patent licence agreement where we have freedom to operate. 

Please get in touch if you are interested installing IONA® Nx in your region. Email This email address is being protected from spambots. You need JavaScript enabled to view it. to receive updates on the IONA® Nx NIPT Workflow availability.

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