Announcement PDF RNS Number : 1582N Genedrive PLC 30 May 2022 genedrive plc ("genedrive" or the "Company") Point-of-Care Genedrive® COV19-ID Kit receives Coronavirus Test Device Approval ("CTDA") genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the UK Medicines and Healthcare Products Regulatory Agency has granted a CTDA enabling the sale of the Genedrive® COV19-ID Kit in the United Kingdom. Genedrive's application for approval, under the requirements that came into force on 28 July 2021 via The Medical Devices (Coronavirus Test Device Approvals Regulations (2021)), was made on 21 December 2021. Since submission for approval, the product has undergone positive external validation, commercial partners have been engaged in specific countries, and product claims have been expanded to include the testing of asymptomatic patients. Information about the Genedrive® COV19-ID Kit can be found at https://www.genedrive.com/assays/cov19-id-assay.php David Budd, CEO of genedrive plc, said: "We are very pleased to have received a CTDA, which now allows the UK access to the fastest point-of-care COVID molecular test. The performance of the test has met CTDA standards in all regards, which positions genedrive well to engage in opportunities as they develop going forwards in the UK." 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 Reverse-Transcription 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 midturbinate nasal swab, the assay targets the ORF1ab and N genes of the SARS-CoV-2 genome, adding robustness against emerging SARS-CoV-2 variants. For further details please contact: genedrive plc David Budd: CEO / Russ Shaw: 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 0500 Walbrook PR Ltd (Media Relations) Paul McManus / Anna Dunphy & Investor +44 (0)20 7933 8780 or genedrive@walbrookpr.com +44 (0)7980 541 893 / +44 (0)7876 741 001 About genedrive plc (http://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, MT-RNR1 for Ototoxicity, certain military biological targets, and a high throughput SARS-CoV-2 assay. 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 MSCBKFBQBBKDAPB