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.
