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COVID-19 assay launched

Published on 01/07/2020
COVID-19 assay launched

COVID-19 assay launched
Launch of Clarigene™ SARS-CoV-2 test (‘RUO’)

Manchester, UK – 30 June 2020: Yourgene (AIM: YGEN), a leading international molecular diagnostics group, announces the launch of its Clarigene™ SARS-CoV-2 test for research use only (‘RUO’).

The Clarigene™ SARS-CoV-2 test is a molecular PCR (polymerase chain reaction) based COVID-19 assay, which detects the SARS-CoV-2 virus RNA* to confirm the presence of the virus. The test is used to detect the presence of the virus and whether individuals are currently infected, not the presence of antibodies. The assay is simple but highly effective with one sample, the viral target and the internal control all in the same PCR well**.

The test kit contains a mastermix, primer and probe sets and is suitable for RNA extracted from a nasopharyngeal swab. The assay has a rapid turnaround time of 1hr 20min following RNA extraction and set up. The competitive assay has been developed to reduce the chance of false negative results being generated, which has been an industry wide problem1. Yourgene’s internal control primers are designed to only detect RNA and not amplify patient DNA, which leads to false negatives. The assays have been benchmarked against data from an independent laboratory assessment body. Preliminary data has shown the test to have 100% specificity.

The Clarigene™ SARS-CoV-2 test will be made available to Yourgene’s customers as evaluation kits, and as previously announced on 26 May 2020, a CE marked in vitro diagnostic kit (‘CE IVD’), for diagnostic use, is still on track for release at the end of July 2020. The CE-IVD version will have two viral targets and assay controls, making it more desirable from the reimbursement perspective across several European regions.

Yourgene already has over 300 laboratory customers and a growing global network of distribution channels in place through which to drive sales of the Clarigene™ SARS-CoV-2 test and CE IVD kits, once approved, targeting a pipeline of opportunities. In addition, the test will be run in Yourgene’s service laboratory in Manchester.

Lyn Rees, CEO of Yourgene, commented: “We are proud to continue our support towards the global COVID-19 effort with the launch of the Clarigene™ SARS-CoV-2 Test (RUO) and I would like to congratulate the Yourgene team who have worked extremely hard to get us to this point. The addition of the Clarigene infectious disease product portfolio will strengthen our offering through our commercial channels and expand and diversify our product range. We remain on track to receive CE mark for the test and I look forward to updating the market at the end of July.”

1. doi: https://doi.org/10.1101/2020.05.13.094839

*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.

**A plate containing several wells that goes into a PCR instrument for the assay to work. Each well contains test and sample reagent.

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

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