Yourgene Health PLC COVID-19 testing service launch; business update (8400N)
26 Mayo 2020 - 1:01AM
UK Regulatory
TIDMYGEN
RNS Number : 8400N
Yourgene Health PLC
26 May 2020
Yourgene Health plc
("Yourgene" or the "Company")
Yourgene COVID-19 testing service launch and business update
Manchester, UK - 26 May 2020: Yourgene (AIM: YGEN), a leading
international molecular diagnostics group, announces it has
expanded its laboratory capabilities to offer COVID-19 testing
service and it is developing its own COVID-19 test kit and
targeting a pipeline of opportunities. In addition, the Company
provides an update on its wider business activities.
Yourgene testing laboratories have now launched a COVID-19
testing service. This service will support private testing demand
where there are defined testing populations such as UK GP
surgeries, private clinics and other corporate clients across UK.
The Company will provide further updates in due course.
Furthermore, the Company announces that it is currently
developing its first infectious disease test called Clarigene(TM)
SARS-CoV-2 test - a molecular PCR based COVID-19 assay, which is
able to detect whether individuals are currently infected. The
Clarigene(TM) SARS-CoV-2 test has produced preliminary data, which
the Directors believe show competitive performance compared to
other market leading products , and also has a rapid turnaround
time and low false negative results.
The Company aims to release a "Research Use Only" version of
Clarigene(TM) SARS-CoV-2 test by the end of June 2020 and a CE
marked in vitro diagnostic kit to follow in July 2020. The test
will initially be a manual assay and development has commenced with
a fully automated version aimed at high throughput laboratories to
follow in the coming months.
Yourgene already has over 300 laboratory customers and a growing
global network of distribution channels in place through which to
drive sales of the new Clarigene infectious disease portfolio of
products. In addition, the test will be run in the Yourgene service
laboratory once it is launched as a CE IVD kit.
The Company continues to explore additional opportunities to
expand its contribution to global COVID-19 testing efforts with
increased usage of its state-of-the-art manufacturing facility at
Citylabs in Manchester, as well as exploring additional routes to
market.
Given this is a new product in a fast-developing market, demand
and uptake is difficult to forecast. Further guidance will be given
in due course.
The core molecular diagnostics business continues to perform in
line with management expectations and remains on track to build on
the strong year end performance announced in the trading update for
the year ended 31 March 2020. The Company remains confident of
receiving CE marking for its Illumina-based IONA(R) test in the
near future and has been informed that the product has now been
recommended for approval and is in the final stages of
evaluation.
Yourgene will announce results for the year ended 31 March 2020
by mid-July and will provide details of the confirmed date in due
course.
Lyn Rees, CEO of Yourgene, commented: "I'm delighted to provide
more details on the direct impact our dedicated and talented team
have made and to share our future ambitions to support the global
COVID-19 effort. The addition of the Clarigene infectious disease
product portfolio strengthens our offering through our commercial
channels and supports one of the strategic pillars of growth - our
product diversification strategy. It's also especially pleasing to
see that the main growth drivers of the business remain on track
and with approval for our new Illumina platform NIPT just around
the corner I look forward to providing further updates on our
exciting new product development pipeline."
This announcement contains inside information for the purposes
of Article 7 of EU Regulation 596/2014.
Yourgene Health plc Tel: +44 (0)161 669 8122
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)
Paul McManus / Lianne Cawthorne Mob: 07980 541 893 / Mob: 07584 391
303
About Yourgene Health plc
Yourgene 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 is also extending its genetic
testing offering into oncology.
Yourgene 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.
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END
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