17 Feb 2022 07:00
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
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 Lyn Rees, Chief Executive Officer | Tel: +44 (0)161 669 8122 investors@yourgene-health.com | |
Barry Hextall, Chief Financial Officer |
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Joanne Cross, Director of Marketing
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Cairn Financial Advisers LLP (NOMAD) | Tel: +44 (0)20 7213 0880 | |
Liam Murray / James Caithie / Ludovico Lazzaretti
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Singer Capital Markets (Joint Corporate Broker) | Tel: +44 (0)20 7496 3000 | |
Aubrey Powell / Tom Salvesen / George Tzimas |
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Stifel Nicolaus Europe Limited (Joint Corporate Broker) | Tel: +44 (0)20 7710 7600 | |
Nicholas Moore / Matthew Blawat / Ben Maddison |
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Walbrook PR Ltd (Media and Investor Relations) | Tel: +44 (0)20 7933 8780 or 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 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.