Genedrive Regulatory News (GDR)

genedrive plc

("genedrive" or the "Company")

New Genedrive® 96 Exporter software

Easy-to-use analysis tool to support high-throughput Coronavirus PCR testing

genedrive plc (LSE: GDR), the near patient molecular diagnostics company, announces that it has developed and now CE marked Genedrive® 96 Exporter, a new IVD software module for automated results interpretation of the Genedrive® 96 SARS-CoV-2 Kit. genedrive is one of only a handful of companies offering a full laboratory workflow solution for the analysis of extracted COVID-19 RNA Polymerase Chain Reaction ("PCR") samples, including the test reagents, instrument protocols, and automated analysis software.

The Genedrive® 96 Exporter has been developed to provide further workflow and usability advantages to the Genedrive® 96 SARS-CoV-2 kit. The software module extracts the raw fluorescence run data from third party high throughput real time PCR platforms, analyses the PCR melt-curve data generated using the Genedrive® 96 SARS-CoV-2 Kit. It displays the interpreted data as 'Positive' or 'Negative' in a graphical user interface and as an exportable report. The interpreted data is then available for further inspection on an individual sample, sample group, or entire 96 well plate basis by the user.

The Genedrive® 96 SARS-CoV-2 Kit is a novel CE Marked PCR assay designed to detect active infection in COVID-19 patients. genedrive's one-step PCR bead format eliminates the need for the time consuming and error-prone reagent preparation required in other open-platform test kits. The proprietary format streamlines laboratory workflow, allowing more tests to be performed in a day. During CE-IVD evaluations, the Genedrive® 96 SARS-CoV-2 Kit achieved 100% sensitivity and 98% specificity in randomised clinical specimens.

David Budd, Chief Executive Officer of genedrive plc, said: "The new Genedrive® 96 Exporter software provides a significant improvement to the native software found on third party PCR platforms, allowing for a more seamless workflow for melt curve PCR analysis in COVID-19 PCR testing when using our assay. The tool was developed by repurposing the clinically validated software algorithms we use in our point-of-care Genedrive® instrument software, underscoring the versatility and value in our core technology platform and providing additional differentiation to genedrive's offerings in the COVID-19 testing market."

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 CE marking of the high throughput Genedrive® 96 SARS-CoV-2 assay, and a Genedrive® Point of Care version of the assay is in development.