- 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.
- 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.