REG - Yourgene Health PLC - US partnership with EKF for NIPT and genomic tests

Yourgene HealthAnnouncement

18/01/2022 07:05

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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
(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
(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 (mailto: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 Broker)    Tel: +44 (0)20 7496 3000
 Aubrey Powell / Tom Salvesen / George Tzimas

 Stifel Nicolaus Europe Limited (Joint Corporate Broker)                                 Tel: +44 (0)20 7710 7600
 Nicholas Moore / Matthew Blawat / Ben Maddison

 Walbrook PR Ltd (Media and Investor Relations)     Tel: +44 (0)20 7933 8780 or yourgene@walbrookpr.com
 Paul McManus / Lianne Applegarth / Alice Woodings  Mob: 07980 541 893 / 07584 391 303 / 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 (http://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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