(“Yourgene” or the “Company”)
CE Marking Technical File submission
Manchester, UK – 17 February 2020: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces that it has submitted its CE Marking Technical File for the Illumina-based IONA® test to its EU notified body, BSI Netherlands.
BSI Netherlands will now audit the CE Marking Technical File and if accepted will issue a European CE Marking Certificate. As soon as regulatory approvals are received the Company will roll the product out across Europe and pursue further regulatory registrations in newly addressable markets throughout 2020 and beyond.
The IONA® test is a non-invasive prenatal test (NIPT) for pregnant women which estimates the risk of a fetus having Down’s syndrome (T21), Edward’s syndrome (T18) and Patau’s Syndrome (T13). The test, a market leader in terms of accuracy, is carried out on a small blood sample taken from the mother’s arm with no risk of miscarriage. It has been developed into a format which is compatible with Illumina’s next-generation sequencing technology.
Lyn Rees, CEO of Yourgene, commented: “We are very excited to bring our IONA® test to market on the Illumina platform. The launch of the test has been greatly anticipated by our laboratory customers and will be a strong driver of our future growth. We look forward to announcing the receipt of our CE Marking certificate and updating shareholders on the plans for commercial launch.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
Yourgene Health plc
Lyn Rees, Chief Executive Officer
Tel: +44 (0)161 669 8122
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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.