TIDMYGEN
RNS Number : 8810X
Yourgene Health PLC
03 September 2020
Yourgene Health plc
("Yourgene" or the "Group" or the "Company")
IONA (R) Nx Launch
Manchester, UK - 3 September 2020: Yourgene (AIM: YGEN), the
international molecular diagnostics group, announces the launch of
IONA(R) Nx NIPT workflow , the Company's new innovative
non-invasive prenatal test ('NIPT'). The IONA Nx seeks to offer
clinical labs a high performing, flexible, scalable and innovative
NIPT service in-house and is developed to run on the Illumina
Nextseq 550 Dx platform for next generation sequencing.
As announced on 15 June 2020, the IONA Nx received a CE mark
across the European Union, including the UK, as well as other
countries that accept the CE-IVD mark. Yourgene will initially
transition existing customers in the UK and France, where the
Company has an existing direct presence to the IONA Nx. The Company
also expects to see uptake of the product in other European
territories where it will utilise its recently strengthened
commercial team in Europe.
In addition, Yourgene will be targeting additional markets
within the Illumina IP territory following regulatory approvals. As
announced on 13 August 2020 Australia's Therapeutics Goods
Association ('TGA') approved the IONA Nx as a medical device Class
3, allowing Southern Cross Diagnostics, Yourgene's Australian
distributor, to commence sales. Further territories covered by the
Illumina licence agreement will also be made available when
regulatory submissions are approved.
Illumina's NGS technology accounts for around 75% of the global
NGS market and the NIPT market in Europe alone is set to grow to
USD $500 million by 2025(1) which puts Yourgene in a strong
position going forward. The Yourgene NIPT service laboratory in
Manchester is in the process of changing over to the IONA Nx and
Yourgene will inform customers when this is live.
About IONA Nx
The IONA Nx uses an innovative new fetal fraction enrichment
step with the Yourgene QS250 instrument, which enriches fetal
fraction by two-fold, reducing the need for as much sequencing and
therefore making it a more cost effective NIPT workflow. The
Yourgene QS250 is powered by the Ranger(R) technology, from Coastal
Genomics which Yourgene acquired in August 2020. The use of the
Yourgene QS250 in an NIPT NGS workflow is an industry step change,
the instrument increases cell free fetal DNA enrichment which
increases sequencing efficiency and improves the performance of
NIPT.
The IONA Nx has a reduced capital footprint with new
instrumentation in the workflow and uses the Yourgene SP150 and
Yourgene QS250 to combine the DNA extraction, sample preparation
and enrichment elements of the workflow ahead of the sequencing
step. This is the first time Yourgene will be making the
instruments commercially available as part of the workflow and
enables customers to obtain the majority of the workflow, including
instruments, reagents, bioinformatics software and workflow
management systems, from one provider.
There are several unique and new product features to the IONA Nx
including >99.99% accuracy (sensitivity and specificity) and an
extended clinical menu, offering whole genome analysis including
Trisomy 21, 18, 13, Sex chromosomal aneuploidies, other autosomal
aneuploidies and optional fetal sex determination, with the
intention to add clinically relevant Microdeletions in the near
future. The IONA Nx is flexible and scalable which makes it
suitable for automated or manual workflow with up to 48 samples per
sequencing run and therefore suitable for low to high throughput
labs. It is one of the fastest automated workflows on the market
and can be performed in just two days, three for manual workflow.
The Atlas Workflow Manager, developed by Yourgene, is available for
the automated workflow to give complete traceability and can also
be customised to integrate with a customer labs own laboratory
information management systems ('LIMS').
For full details of the IONA Nx please visit:
www.yourgene-health.com/nipt/iona-nx
Lyn Rees, CEO of Yourgene Health plc, stated: " We have already
expanded our European sales team with key appointments in UK,
France, Germany to support the commercial roll-out of the IONA Nx
and w e will look to give updates on key milestones such as
regulatory approval and new customer wins . Our IONA test has a
strong reputation for reliability and accuracy and was the first CE
marked NIPT product for the European market. The new IONA Nx
combines this gold standard for reliability and accuracy with a
market leading sequencer and we believe this will be a strong
driver of growth in the future.
"We expect to see accelerated double-digit growth in our NIPT
business this calendar year. We are confident that a this will be
delivered through a mix of organic growth across our existing NIPT
customer base, the transition of existing customers to IONA Nx in
current territories, as well through securing new customers and
commencing sales in new territories."
(1)
https://www.prnewswire.com/news-releases/european-500-million-non-invasive-prenatal-testing-market-to-2025-300728591.html
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.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements. These forward-looking statements are not historical
facts but rather are based on the Company's current expectations,
estimates, and projections about its industry; its beliefs; and
assumptions. Words such as 'anticipates,' 'expects,' 'intends,'
'plans,' 'believes,' 'seeks,' 'estimates,' and similar expressions
are intended to identify forward-looking statements. These
statements are not guarantees of future performance and are subject
to known and unknown risks, uncertainties, and other factors, some
of which are beyond the Company's control, are difficult to
predict, and could cause actual results to differ materially from
those expressed or forecasted in the forward-looking statements.
The Company cautions security holders and prospective security
holders not to place undue reliance on these forward-looking
statements, which reflect the view of the Company only as of the
date of this announcement. The forward-looking statements made in
this announcement relate only to events as of the date on which the
statements are made. The Company will not undertake any obligation
to release publicly any revisions or updates to these
forward-looking statements to reflect events, circumstances, or
unanticipated events occurring after the date of this announcement
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