Yourgene Health PLC Clarigene(R) SARS-CoV-2 Product Update (1531L)

TIDMYGEN

RNS Number : 1531L

Yourgene Health PLC

11 January 2021

Yourgene Health plc

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

Clarigene(R) SARS-CoV-2 Product Update

and Partnerships with CityDoc and ReCoVa-19

Manchester, UK - 11 January 2021: Yourgene (AIM: YGEN), the international molecular diagnostics group, announces that following the Company's statement on 24 December 2020, regarding the new virus strain (VUI-202012/01 SARS-CoV-2 variant), Yourgene's wet lab testing is now complete and has confirmed that the performance of the Clarigene(R) SARS-CoV-2 assay is not impacted by any currently known mutations in the VUI-202012/01 strain.

The wet lab testing followed a detailed in silico (Computer) analysis of the mutations in the new SARS-CoV-2 variant, to assess the reliability of Yourgene's existing Clarigene(R) product. Unlike many other assays on the market, the Clarigene(R) 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, in this new virulent strain. The Company has also implemented an ongoing rigorous internal surveillance programme to ensure continued monitoring for the development of new viral strains. This includes database monitoring for SARS-CoV-2 variants with mutations in the N and the E gene which fall around the assay primers and probes, as well as impact assessment on these mutations on assay performance, evaluated by in silico analysis and wet lab confirmation.

Following the confirmation of the performance of the Clarigene(R) SARS-CoV-2 assay against the new virus strain, Yourgene have partnered with CityDoc Medical Limited ("CityDoc"), a 15-year old healthcare business and one of the UK's largest private vaccination and medical testing companies with over 150+ clinics across the UK, to oversee the customer management and offer responsive clinical support for Yourgene's Clarigene(R) test, for the UK Government's Test To Release for international travellers scheme. CityDoc will manage the e-commerce function and logistics by allowing customers to order a sample collection kit and returning the test sample to the Yourgene laboratory. In addition, another key customer, ReCoVa-19 Limited works alongside Yourgene and CityDoc to provide access to their customer-facing COVID testing and wellness monitoring app, which enables sample tracking and customers to access their test results.

Lyn Rees, CEO of Yourgene commented: "We are pleased to confirm that our Clarigene(R) test is not compromised by the recently analysed mutations in the SARS-CoV-2 virus and believe that our ongoing internal surveillance for new virus strains shows our commitment to offering our customers the quality products they expect and deserve. We have a great and reliable product in the Clarigene(R) test and look forward to working with CityDoc and ReCoVa-19 Limited, in order to support the economy by aiding the travel industry's return to normality."

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.

 
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About Yourgene Health plc

Yourgene 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 develops and commercialises simple and accurate molecular diagnostic solutions, for reproductive health and molecular genetics. The Group's products include non-invasive prenatal tests (NIPT) for Down's Syndrome and other genetic disorders, Cystic Fibrosis screening tests, invasive rapid aneuploidy tests, male infertility tests and genetic disease tests. Yourgene's commercial footprint is already established in the UK, Europe, the Middle East, Africa and Asia.

Our product development, research service and commercial capabilities extend across the lifecycle of genetic test development including regulatory submissions. Through our technical expertise and partnerships, Yourgene is also extending its genetic testing offering into oncology.

Yourgene is headquartered in Manchester, UK with offices in Taipei and Singapore, 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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January 11, 2021 02:00 ET (07:00 GMT)