Announcement PDF RNS Number : 8438C Genedrive PLC 22 October 2020 genedrive plc ("genedrive" or the "Company") Point-of-Care solution to detect SARS-CoV-2 virus in saliva Development update genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces it has completed the assay design for the Company's Point-of-Care ("POC") solution for COVID-19 testing and is now generating very promising analytical data aligned to market requirements. The Genedrive® SARS-CoV-2 POC Kit is being designed to detect SARS-CoV-2, the virus causing COVID-19, amplified directly from a saliva sample without the need to extract viral RNA. This expands the potential use areas of the product and importantly, allows for rapid testing to be performed while a patient is present. When running on the Genedrive® POC device the chemistry is detecting a positive SARS-CoV-2 sample in approximately 15 minutes, with fully negative samples taking just over 20 minutes to resolve. The limit of detection is in line with the UK's MHRA Target Product Profile sensitivity requirements. The Genedrive SARS-CoV-2 POC Kit follows a similar workflow that has already been validated in the Company's Genedrive® HCV-ID Kit which received WHO prequalification earlier this year. The Company is targeting the end of the calendar year for completion of preliminary product evaluations, with full release of the final CE Marked system in Q1 2021 allowing for thorough clinical testing requirements. Additionally, the Company is working to progress to a version 2 of the product, which would accept a similar freeze-dried PCR bead format previously developed for the high throughput Genedrive® 96 SARS-CoV-2 Kit. This will allow for lower production costs and highly scalable manufacturing capacity. David Budd, Chief Executive Officer of genedrive plc, said: "Rapid testing for current infection is a cornerstone to any track and trace programme, to quickly accessing current infection, to limiting infection, and to giving assurance to people concerned about their status. We believe the Genedrive® POC solution can contribute significantly to the ongoing management of this global health crisis." genedrive plc David Budd: CEO / Matthew Fowler: CFO +44 (0)161 989 0245 Peel Hunt LLP (Nominated Adviser and Joint Broker) James Steel / Oliver Jackson +44 (0)20 7418 8900 finnCap (Joint Broker) Geoff Nash / Kate Bannatyne / Alice Lane +44 (0)20 7220 0500 Walbrook PR Ltd (Media & Investor Relations) Paul McManus / Anna Dunphy +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, certain military biological targets, and has tests in development for tuberculosis (mTB). The Company recently announced the development of a high throughput SARS-CoV-2 assay and a Genedrive® Point of Care version of the assay, both based on Genedrive® PCR chemistry. 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 MSCKKDBDOBDDDKB