YGEN.L Regulatory News (YGEN)

Yourgene Health plc

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

COVID-19 update: approved provider for UK Government and response to new virus strain

Manchester, UK - 24 December 2020: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces that Yourgene Genomic Services has been added to the UK Government's approved COVID-19 private testing providers list for the Test to Release for International Travel scheme introduced on 15 December 2020 ("Test to Release"), and also for general coronavirus testing. The Company has also conducted in silico analysis studies into the effect of the new virus strain which suggests that the performance of its test will be unaffected.

The Test to Release scheme is a UK Government backed programme, designed to reduce quarantine periods for travellers arriving in the UK. The Group is waiting for the government website to be updated to reflect this in due course. Through the Test to Release scheme, passengers have the opportunity to pay for a COVID-19 test through the list of approved private providers, to find out if they are able to reduce the self-isolation period after international travel. Yourgene Genomic Services has the full COVID-19 testing service offering required to meet the Department of Health & Social Care's 15 minimum standards*. Yourgene will go live with the Test to Release scheme in early January 2021 but the general coronavirus testing offering is already live.

Following the announcement of a new virulent strain of SARS-CoV-2 by the UK's COVID-19 Genomics UK consortium, known as VUI-202012/01, Yourgene has conducted preliminary in silico (computer) analysis of the mutations in this new variant to assess the reliability of the Company's existing Clarigene® product. Unlike some other tests on the market, the Clarigene® SARS-CoV-2 assay does not rely on amplification of the S gene, where one of the key VUI-202012/01 variants (N501Y) is located and the results of the in silico analysis suggest that the performance of the Clarigene® assay will be unaffected by these mutations in VUI-202012/01. For further customer assurance the Company is conducting additional 'wet lab' testing to confirm the in silico findings.

Lyn Rees, CEO of Yourgene Health plc, said: "We are extremely pleased to be an approved private provider for the Test to Release scheme to support international travel to the UK, as well as more general UK COVID-19 testing. This approval confirms the high standards and service levels we have been setting for our COVID-19 testing partners and in our wider Genomic Services laboratory offering. We continue to monitor the evolving situation in order to remain at the forefront of fighting the pandemic, and to expand our capabilities in a way that accelerates our wider business strategy."

*More information on the minimum standards set out by the Department of Health & Social Care can be found here: https://bit.ly/3pfSDnZ

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014. The Directors of the Company take responsibility for this announcement.

About Yourgene Health

Yourgene Health 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 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.