Yourgene Health PLC US distribution agreement for DPYD &other products (5071Z)
September 21 2020 - 1:00AM
UK Regulatory
TIDMYGEN
RNS Number : 5071Z
Yourgene Health PLC
21 September 2020
Yourgene Health plc
("Yourgene" or the "Group" or the "Company")
US distribution agreement for DPYD and other products
Manchester, UK - 21 September 2020: Yourgene (AIM: YGEN), the
international molecular diagnostics group, announces that it has
appointed Immuno-Biological Laboratories Inc ('IBL-America'), a
supplier of in-vitro diagnostic kits for the medical device and
research industry, as a non-exclusive distributor for several PCR
('polymerase chain reaction') tests across Yourgene's reproductive
health and oncology portfolios in the US.
The distribution agreement initially includes the Elucigene(R)
DPYD assay, which tests whether cancer patients can be at risk of
significant and potentially lethal side effects caused by the 5FU
chemotherapy treatment. In the US, there are approximately
500,000(1) 5FU chemotherapy treatments carried out per annum.
Following the launch of the CE marked Elucigene DPYD in Europe,
Yourgene now has over 20 hospitals and cancer centre customers
routinely using the DPYD assay. As announced on 14 February 2020,
the Company also has approval from the Therapeutic Goods
Administration ('TGA') in Australia to allow the Company's
Australian distribution partner, Southern Cross, to market and
distribute the product in Australia.
In addition to the DPYD assay, the Company's cystic fibrosis,
male factor infertility and invasive aneuploidy diagnostic products
will also be sold by IBL-America which, together with the DPYD
assay, represents what the Company believes to be an addressable
market of over GBP30m per annum. Yourgene's products will initially
be sold as Research Use Only ('RUO') to the research sector and to
CLIA-certified laboratories for in-house validation prior to
clinical use, with the potential for full FDA registration later
depending on customer demand. Minneapolis-based IBL-America has
been providing high quality laboratory reagents to the US research
and clinical markets for over 20 years with a focus on customer and
product support.
Lyn Rees, CEO of Yourgene, commented: "The appointment of
IBL-America is an important pillar within our plans to penetrate
the largest diagnostics market in the world with our full portfolio
across the whole genomic testing lifecycle. We have a strong
pipeline of US-oriented product and technology partnerships and
look forward to updating investors as these opportunities
crystallise."
(1)
https://fennecpharma.com/wp-content/uploads/2014/01/Eniluracil-Way-Forward-2014.pdf
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
N+1 Singer (Joint Corporate Broker) Tel: +44 (0)20 7496 3000
Aubrey Powell / Tom Salvesen / George
Tzimas
Stifel Nicolaus Europe Limited (Joint 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, for reproductive health and
molecular genetics. 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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