REG - Yourgene Health PLC - Successful CTDA desktop review

Yourgene HealthAnnouncement

17/02/2022 07:00

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RNS Number : 9332B  Yourgene Health PLC  17 February 2022

Yourgene Health plc

("Yourgene" or the "Group" or the "Company")

 

Successful CTDA desktop review

Approval for sale of Clarigene® SARS-CoV-2 Test in the UK

 

Manchester, UK - 17 February 2022: Yourgene (AIM: YGEN), a leading
international molecular diagnostic group, announces that it has received
confirmation from the UK Health Security Agency that the Clarigene®
SARS-CoV-2 test (CE-IVD) ("Clarigene®") has been approved under the
requirements set out in the Medical Devices (Coronavirus Test Device
Approvals) (Amendment) Regulations 2021 ("CTDA regulations").

 

The product will be included on the register of products that have been
approved under 38A(5) of the Medical Devices Regulations 2002, in due course:

https://www.gov.uk/government/publications/covid-19-test-validation-approved-products
(https://www.gov.uk/government/publications/covid-19-test-validation-approved-products)
 

 

Yourgene’s primary source of COVID-19 revenues, PCR testing and sequencing
services, were unaffected by the extended time taken to receive this approval
under these newly introduced UK regulations, as they were not reliant on
selling Clarigene® or Clarigene® achieving approval under CTDA regulations.

 

Following approval under CTDA regulations, Yourgene can now actively market
the Clarigene® test to new UK customers to meet the needs of continued
seasonal PCR testing. Clarigene will be one of a small number of UK
manufacturers with COVID-19 testing products currently approved for sale in
the UK.

 

Having recently provided upgraded guidance for the current financial year on
17 January 2022, Yourgene intends to provide a further progress update on
trading following the March year end.

 

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
                                                    (mailto:yourgene@walbrookpr.com)
 Paul McManus / Alice Woodings                      Mob: 07980 541 893 / 07407 804 654

 

 

About Yourgene Health

 

Yourgene Health is an international molecular diagnostics group which develops
integrated genomic technologies and services enabling genomic 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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