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CE-IVD mark received for Illumina-based IONA® test

Published on 01/07/2020
CE-IVD mark received for Illumina-based IONA® test

CE-IVD mark received for Illumina-based IONA® test
Non-invasive prenatal screening test to launch as IONA® Nx

Manchester, UK – 15 June 2020: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces that it has received CE-IVD marking for its Illumina-based IONA® test, the Company’s flagship non-invasive prenatal test (“NIPT”) product for Down’s syndrome and other genetic disorders.

The newly approved test, the IONA® Nx NIPT Workflow (“IONA® Nx”), will now be readied for commercial launch across the European Union, including the UK, as well as other countries that accept the CE-IVD mark.

The IONA® Nx, is an in vitro nucleic acid screening test that measures the likelihood that a pregnant woman is carrying a fetus with Trisomy 13, 18 or 21. It is a laboratory based test that has been developed to run on the Illumina’s NextSeq 550Dx instrument, a next generation sequencing (“NGS”) platform.

As Europe emerges from the restrictions implemented due to the coronavirus pandemic, the Company expects to roll-out the IONA® Nx to its laboratory customers across the UK and Europe in the coming months, as well as establishing its own laboratory based test service using IONA® Nx at the Company’s facilities in Manchester.

Yourgene will work with its customers to allow technical installations to take place that ensure social distancing within the lab and remote work will be undertaken to ensure customers have access to the IONA Nx as soon as possible, despite current travel restrictions.

Key features of the new IONA Nx NIPT workflow include:
– IONA® Nx utilises advanced proprietary sample preparation technologies
– The test process has been simplified therefore reducing the need for instrumentation capital expenditure
– IONA® Nx has been designed to offer flexibility and scalability to suit varying customer needs

Further details about IONA® Nx will be announced following the full commercial launch and a further update will be provided to shareholders in due course.

Lyn Rees, CEO of Yourgene, commented: “We’re delighted to announce CE marking for our Illumina-based IONA® test, the IONA® Nx. I am very proud of the Yourgene team who have worked incredibly hard to make the market leading accuracy of the IONA® NIPT product available to labs across Europe that use Illumina’s next generation sequencing technology. Given that Illumina’s NGS technology accounts for around 75% of the global NGS market, we look forward to working in partnership with them to expand our reach into significant parts of the market that were previously unavailable to us.”

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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