Business
South African approval
South African approval.
About this update from Genedrive Plc
[{"type":"text","content":"\n \n \n \n RNS Number : 5096A\n Genedrive PLC\n 30 September 2020\n \n \n \n \n \n \n \n The information contained within this Announcement is deemed by the Company to constitute inside information as stipulated under the Market Abuse Regulation (EU) No. 596/2014. Upon the publication of this Announcement via the Regulatory Information Service, this inside information is now considered to be in the public domain.\n \n \n \n \n \n genedrive plc\n \n \n (\"genedrive\" or the \"Company\")\n \n \n Genedrive® 96 SARS-CoV-2 Kit approved in South Africa\n \n \n genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that the Company's Genedrive® 96 SARS-CoV-2 Kit has received approval from the South African Health Products Regulatory Authority. The Genedrive® kit was submitted for evaluation in June 2020.\n \n \n \n \n \n Under the approval, the Kit can now be distributed and sold within South Africa. Genedrive products are supplied in the country, and more broadly within Africa, via the Sysmex EMEA organisation. \n \n \n \n \n \n Since the original evaluation, genedrive has expanded the number of PCR platforms and RNA isolation kit providers which are validated for the Company's Kit. This is important for markets such as South Africa where high testing volumes are supported by the prevalence of automated/robotic RNA extraction instruments, and the variety of testing platforms is diverse owing to a split between public and private testing facilities. \n \n \n \n \n \n \n David Budd, Chief Executive Officer of \n \n genedrive plc, said \"This is an important milestone in the commercialisation of our COVID-19 Kit in the region. South Africa is a key territory for our distributors and this approval will now provide an acceleration of commercial sales activity in the area.\"\n \n \n \n \n \n \n \n \n The person responsible for the release of this Announcement on behalf of genedrive plc is Matthew Fowler, Chief Financial Officer.\n \n \n \n \n \n \n \n \n genedrive plc\n \n \n \n \n +44 (0)161 989 0245\n \n \n \n \n \n \n David Budd: CEO / Matthew Fowler: CFO\n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n \n Peel Hunt LLP (Nominated Adviser and Joint Broker)\n \n \n \n \n +44 (0)20 7418 8900...