CE-IVD Mark for Clarigene™ SARS-CoV-2 test

Yourgene Health plc

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

CE-IVD Mark for Clarigene™ SARS-CoV-2 test

Manchester, UK - 3 August 2020: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces that it has achieved CE-IVD marking for its Clarigene™ SARS-CoV-2 in vitro diagnostic kit, for diagnostic use. The CE-IVD version of the Clarigene™ SARS-CoV-2 test will be used in Yourgene's high throughput COVID-19 service lab in Manchester and will allow Yourgene to provide corporate partners and healthcare settings, such as care homes and private GP practices, with a fast and reliable COVID-19 lab testing service.

The Clarigene™ SARS-CoV-2 CE-IVD test is a RT-qPCR (real-time quantitative polymerase chain reaction) assay which detects the presence of SARS CoV-2 viral RNA*. The assay uses two viral RNA targets, nucleocapsid gene ('N') and envelope gene ('E'), which are SARS-CoV-2 specific and this prevents any cross reactivity with other Coronaviruses. The use of dual viral targets and assay controls provides a more reliable result, whilst also making it more desirable across several European regions which require the dual viral targets for reimbursement.

Clinical validation of the test has shown >99.9% accuracy with no false positive or false negative results. Additional studies have shown 100% repeatability data and an average >99.7% reproducibility.

The Clarigene™ test only detects SARS CoV-2 RNA and shows no cross reactivity with other respiratory viruses. Inadequate sample collection has been a significant issue in the global pandemic and the ClarigeneTM test kit has an internal control that detects poor-quality samples to give an invalid result, allowing greater confidence in negative results.

On 31 July 2020, Elucigene Diagnostics, part of the Yourgene Health group, made a manufacturer's Declaration of Conformity that their Clarigene™ SARS CoV-2 test complies with the provisions of Directive 98/79/EC on In Vitro Diagnostic Medical Devices and that the in vitro diagnostic medical device can now be CE marked and placed on the European market. The Clarigene SARS CoV-2 CE marked test will be rolled out through our direct sales teams and distribution network and additional submissions are in progress for other regulatory jurisdictions.

Lyn Rees, CEO of Yourgene, commented: "I would like to congratulate the Yourgene team for their hard work in achieving the CE-IVD mark for the Clarigene™ SARS-CoV-2 Test in such a short amount of time. There is a significant opportunity to drive sales of the Clarigene™ SARS-CoV-2 kits, however we understand that the COVID-19 testing market is dynamic and with this in mind, we will commit to updating shareholders on a quarterly basis on the commercial take-up of this product."

*Ribonucleic acid (RNA) is a polymeric molecule essential in various biological roles in coding, decoding, regulation and expression of genes. RNA and DNA are nucleic acids, but RNA is needed to detect the COVID-19 virus.

This announcement contains inside information for the purposes of Article 7 of EU Regulation 596/2014.

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 precision medicine. 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.