South African approval

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.

genedrive plc

("genedrive" or the "Company")

Genedrive® 96 SARS-CoV-2 Kit approved in South Africa

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.

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.

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.  

David Budd, Chief Executive Officer of 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."

The person responsible for the release of this Announcement on behalf of genedrive plc is Matthew Fowler, Chief Financial Officer.

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 availability of a high throughput SARS-CoV-2 assay and the development of a Genedrive® Point of Care version of the assay, both based on Genedrive® PCR chemistry.