Announcement PDF RNS Number : 4160W Genedrive PLC 22 December 2021 genedrive plc ("genedrive" or the "Company") UK CTDA application for Point-of-Care Genedrive® COV19-ID kit Sensitivity and specificity data submitted meets MHRA requirements Performance data supports successful Omicron detection genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that, further to the announcement on 29 November 2021 confirming submission for CEIVD certification for the Genedrive® COV19-ID Kit, expanded product validation requirements have now been completed and the Company has filed for approval to sell the product in the United Kingdom under the new Coronavirus Test Device Approvals (CTDA) regulations1. CTDA regulations came into effect on 1 Nov 2021 and place specific registration, review and performance requirements on suppliers of COVID-19 diagnostic products into the United Kingdom. The expanded clinical validation sample cohort required for CTDA approval was referenced against the Thermo Fisher TaqPath COVID-19 RT-PCR test. In the 264 samples, specificity was 98%, and sensitivity was 98% in samples with viral load >500 copies per ml. This cohort included samples of confirmed Omicron variant, all of which were successfully detected. The sensitivity and specificity of the Genedrive® COV19-ID assay on the entire cohort met the current requirements of the UK's MHRA Target Product Profile for SARS-CoV-2 Point-of-Care molecular diagnostic tests. Potential commercial partners, testing suppliers, or clinical professionals interested in the new Genedrive® COV19-ID Kit can contact the Company via info@genedrive.com. Information about the new Genedrive® COV19-ID Kit can be found at https://www.genedrive.com/assays/cov19-id-assay.php David Budd, CEO of genedrive plc, said: "CTDA performance data builds on the data already generated for CE certification, and demonstrates that the product meets the expanded UK requirements for Point-of-Care COVID-19 molecular tests. The next milestone is approval by the Department of Health and Social Care, however, no assured timeline is provided on how long the review under CTDA regulations will take, given a current backlog in their reviews. We have confidence in our data and the application is another positive step that allows us now to progress UK focused commercial discussions." The Genedrive® COV19-ID kit is a rapid molecular diagnostic test that delivers positive results as quickly as 7.5 minutes and negative results at 17 minutes. It utilises ReverseTranscription Loop Mediated Isothermal Amplification (RT-LAMP) and a proprietary buffer formulation to achieve rapid results without requirement for user viral extraction steps. Performed directly from a mid-turbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV2 variants. For further details please contact: genedrive plc David Budd: CEO / Matthew Fowler: CFO +44 (0)161 989 0245 Peel Hunt LLP (Nominated Adviser and Joint Broker) James Steel +44 (0)20 7418 8900 finnCap (Joint Broker) Geoff Nash / Kate Bannatyne / Alice Lane +44 (0)20 7220 500 Walbrook PR Ltd (Media Relations & IR) Paul McManus +44 (0)20 7933 8780 or genedrive@walbrookpr.com +44 (0)7980 541 893 About genedrive plc - www.genedriveplc.com genedrive plc is a molecular diagnostics company developing and commercialising a low cost, rapid, versatile, simple to use and robust point of need molecular diagnostics platform for the diagnosis of infectious diseases and for use in patient stratification (genotyping), pathogen detection and other indications. The Company has assays on market for the detection of HCV, certain military biological targets and a high throughput SARS-CoV-2 assay. The Company has also recently released a test to help in the prevention of hearing loss (Genedrive® MT-RNR1 Kit) caused by specific antibiotics in neonates. 1 https://www.gov.uk/government/publications/assessment-and-procurement-ofcoronavirus-covid-19-tests/covid-19-test-approval-step-2-process-for-desktopreview#overview-of-the-process This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com. RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our Privacy Policy. END MSCTBBMTMTTTTTB