Yourgene Health PLC CE-IVD Certification renewal (6978N)
26 September 2019 - 4:00PM
UK Regulatory
TIDMYGEN
RNS Number : 6978N
Yourgene Health PLC
26 September 2019
Yourgene Health plc
("Yourgene" or the "Company")
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(R) 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(R) test from early next year."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
Yourgene Health plc Tel: +44 (0)161 667 1053
Lyn Rees, Chief Executive Officer investors@yourgene-health.com
Barry Hextall, Chief Financial Officer
Joanne Cross, Director of Marketing
Cairn Financial Advisers LLP (NOMAD) Tel: +44 (0)20 7213 0880
Liam Murray / James Caithie / Ludovico
Lazzaretti
Stifel Nicolaus Europe Limited (Sole Tel: +44 (0)20 7710 7600
Corporate Broker)
Nicholas Moore / Matthew Blawat / Ben
Maddison
Walbrook PR Ltd (Media and Investor Tel: +44 (0)20 7933 8780 or yourgene@walbrookpr.com
Relations) Mob: 07980 541 893 / 07584 391 303
Paul McManus / Lianne Cawthorne / 07876 741 001
/ Anna Dunphy
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.
This information is provided by RNS, the news service of the
London Stock Exchange. RNS is approved by the Financial Conduct
Authority to act as a Primary Information Provider in the United
Kingdom. Terms and conditions relating to the use and distribution
of this information may apply. For further information, please
contact rns@lseg.com or visit www.rns.com.
END
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