TIDMYGEN
RNS Number : 7436Y
Yourgene Health PLC
18 January 2022
Yourgene Health plc
("Yourgene" or the "Company")
US partnership with EKF Diagnostics for NIPT and additional
genomic tests
Collaboration with EKF Diagnostics to use its accredited US
laboratories for NIPT and Oncology testing
Manchester, UK - 18 January 2022: Yourgene (AIM: YGEN), a
leading international molecular diagnostics group, announces that
it has signed a strategic partnership agreement with EKF
Diagnostics Holdings plc ("EKF", AIM: EKF), a point-of-care
business with accredited laboratory testing capabilities in the US,
whereby EKF will offer an NIPT service to the US market based on
Yourgene's proprietary non-invasive prenatal technology for an
initial 5-year period.
Recently acquired by EKF, Advanced Diagnostics Laboratory LLC
("ADL Health"), a Texas based PCR-focused testing laboratory
certified under the Clinical Laboratory Improvement Amendments
("CLIA") for high complexity testing, has the in-house testing
capabilities to broaden its diagnostics offering into NIPT through
a partnership with Yourgene.
The adoption for NIPT in the US has accelerated with recent
guidelines issued from American College of Obstetricians and
Gynecologists ("ACOG") recommending NIPT to be made available to
all pregnant women(1) . As part of the agreement, Yourgene will
provide ADL Health Laboratories with access to their proprietary
reagents and NGS analysis software as part of a technology transfer
agreement to enable them to build a rapid turnaround NIPT service
for the US market. Currently in the US, the majority of NIPT of
samples are sent to large central testing laboratories in the US,
which are costly and experience lengthy lead times. In contrast,
the new ADL NIPT service will offer rapid turnaround times as the
NIPT workflow can be performed in as little as 48 hours, enabling a
competitive response and allowing both companies to gain traction
in this large growing market. The US Non-Invasive Prenatal Testing
(NIPT) market is expected to reach a valuation of USD 2.5 Billion
by 2028(2) .
As part of the collaboration, Yourgene would provide ADL a range
of tests from the Company's additional PCR portfolio for screening
Cystic Fibrosis, rapid aneuploidy assay and DPYD (Chemotherapy
toxicity test) tests, creating a wider range of reproductive
healthcare products and allowing Yourgene to enter the oncology
market in the US for the first time.
Mike Salter, Chief Executive Officer of EKF, commented: "We are
extremely pleased to have formed this partnership with Yourgene,
allowing EKF to offer NIPT and oncology tests as part of its
proposed strategy of expanding its CLIA laboratory testing
portfolio beyond COVID-19 assays. We are thrilled to be growing
further our reach within the largest healthcare market in the world
and look forward to working with Yourgene going forward."
Lyn Rees, Chief Executive Officer of Yourgene, commented: "We
are thrilled to have entered into this collaboration with EKF and
ADL Health, a well-established group in the US with a large
clinical network of customers positioned to increase uptake of the
tests. This partnership is testament to the strength of our
technical capabilities and accelerates our US growth plans to
broaden our portfolio in the region with strategic partners. I am
excited to be working with EKF and this partnership is a great
platform for growth within the largest healthcare market in the
world."
1. ACOG Practice Bulletin No. 226. American College of
Obstetricians and Gynecologists. Obstet Gynecol 2020;136:e48-69),
summarised at
https://www.acog.org/advocacy/policy-priorities/non-invasive-prenatal-testing
2.
http://www.researchandmarkets.com/reports/5354677/u-s-non-invasive-prenatal-testing-market
This announcement contains inside information for the purposes
of the UK Market Abuse Regulation.
The Directors of the Company take responsibility for this
announcement.
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
Singer Capital Markets (Joint Corporate Tel: +44 (0)20 7496 3000
Broker)
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 Applegarth Mob: 07980 541 893 / 07584 391 303
/ Alice Woodings / 07407 804 654
About Yourgene Health
Yourgene Health is an international molecular diagnostics group
which develops integrated genomic technologies and services
enabling precision medicine. The group works in partnership with
global leaders in DNA technology to advance diagnostic science.
Yourgene primarily develops, manufactures, and commercialises
simple and accurate molecular diagnostic solutions, for
reproductive health, precision medicine and now infectious
diseases. The Group's flagship products include non-invasive
prenatal tests (NIPT) for Down's Syndrome and other genetic
disorders, Cystic Fibrosis screening tests, invasive rapid
aneuploidy tests, and a recent extension into the oncology space
with DPYD genotyping.
The launch of Yourgene Genomic Services has enabled Yourgene to
offer a global laboratory service network equipped to be a full
life-cycle partner for clinical, research and pharmaceutical
organisations to support partners at the preclinical, clinical, and
post-market stages to develop, manufacture, obtain regulatory
approval and commercialise new products and services. In addition,
Yourgene Genomic Services offers an NIPT and high throughput COVID
testing service.
In August 2020, Yourgene acquired Coastal Genomics , Inc., a
sample preparation technology company based in Vancouver, Canada,
enabling the Company to extend its offering and IP portfolio in the
DNA sample preparation sector. The acquisition increased Yourgene's
geographical penetration into the US and Canada, supplementing
existing coverage in the UK, Europe, MEA and Asia.
Yourgene Health is headquartered in Manchester, UK with offices
in Taipei, Singapore, the US and Canada, 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
except as required by law or by any appropriate regulatory
authority.
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