Announcement PDF RNS Number : 1384X Genedrive PLC 30 April 2021 genedrive plc ("genedrive" or the "Company") Genedrive COVID-19 PCR test approved by Indian regulator genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces that the Genedrive® 96 SARS-CoV-2 Kit has been formally approved by the Indian Council of Medical Research ("ICMR"). The Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 100% specificity in the performance evaluation conducted by the ICMR. The Company will now commence commercial activities in India through its existing distributor Divoc Health and will also be seeking additional routes to the market. David Budd, CEO of genedrive plc, said: "We are very happy to achieve formal registration of our COVID PCR tests in India. Although the process took longer than anticipated, the performance data is excellent and will support the commercial process and customer engagement. Formal product approval is an excellent testament to our technology." The Genedrive® 96 SARS-CoV-2 Kit is a novel Polymerase Chain Reaction ("PCR") assay designed to detect active SARS-CoV-2 infection in COVID-19 patients. genedrive's proprietary "ready-to-go" solid PCR bead format eliminates the need for reagent preparation or cold temperature storage, making it a preferable solution for high temperature countries such as India. The format streamlines laboratory workflow, allowing a patient sample to be mixed with a single bead and then tested on a variety of third-party RT-PCR platforms. The test is validated for use on certain Biorad, ThermoFisher, and Roche PCR platforms. Given the escalating infection rate in the country, this week India began to allow the import of certain COVID test kits with foreign registrations, including CE-Marking, without the need for ICMR approval. The country has also introduced pricing controls into the public market, setting a dynamic that does favour the provision of "basic" tests. The Company believes however that formal performance evaluation data and ICMR approval will contribute positively to commercial efforts and premium products such as gendrive's can play a part in the need for COVID-19 testing. 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 / Victoria Erskine +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 released a high throughput SARS-CoV-2 assay and has in development a Genedrive® Point of Care version of the assay, both based on Genedrive® 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 REAEAXLNAELFEFA