CE-IVD Certification renewal
Manchester, UK – 26 September 2019: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces that in preparation for a 2020 product launch and as a contingency for BREXIT, the Company has successfully transferred its quality accreditation process to a new Notified Body, BSI NL (Netherlands), allowing the Company to continue to sell its systems in the European Economic Area (EEA).
As part of this transfer, Yourgene has been issued with a renewed CE-IVD Certificate from BSI NL covering the design and manufacture of its IONA® test, having been successfully audited against the requirements of the European Union In Vitro Diagnostic Directive (98/79/EC). Under the new EC Certification the Company’s CE-IVD mark will be valid until 25 January 2021. The new Certificate also enables the Company to complete the appointment of an identified EU-based Authorised Representative, to protect against potential no-deal Brexit scenarios.
Lyn Rees, CEO of Yourgene, commented:
“The smooth and successful transfer to our new Notified Body in the Netherlands is a testament to the regulatory team at Yourgene and to the robust systems we have in place for quality assurance. The move to BSI NL is a key part of our Brexit contingency planning and also prepares us for the launch of our new Illumina-based version of the IONA® test from early next year.”
This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.
Yourgene Health plc
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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.