Yourgene Health plc
(“Yourgene” or the “Group” or the “Company”)
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.
Yourgene Health plc
Lyn Rees, Chief Executive Officer
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About Yourgene Health
Yourgene Health is an international molecular diagnostics group which develops and commercialises genetic products and services. The group works in partnership with global leaders in DNA technology to advance diagnostic science.
Yourgene develops and commercialises simple and accurate molecular diagnostic solutions, primarily for reproductive health. The Group’s products include non-invasive prenatal tests (NIPT) for Down’s Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, male infertility tests and genetic disease tests. Yourgene’s commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.
Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions. Through our technical expertise and partnerships, Yourgene Health is also extending its genetic testing offering into oncology.
Yourgene Health is headquartered in Manchester, UK with offices in Taipei and Singapore, and is listed on the London Stock Exchange’s AIM market under the ticker “YGEN”. For more information, visit www.yourgene-health.com and follow us on twitter @Yourgene_Health.