Cytiva collaboration on Coronavirus PCR Test

genedrive plc

("genedrive" or the "Company")

Genedrive and Cytiva (formerly GE Healthcare Life Sciences) collaborate on Coronavirus

(SARS-COV-2) PCR Test Development

Genedrive plc (AIM: GDR), the near patient molecular diagnostics company, announces it has entered into an agreement with Cytiva (formerly GE Healthcare Life Sciences) for the development of its Genedrive® 96 SARS-CoV-2 assay for use on lab-based PCR instruments. This is one of two assay programmes the Company is developing following an announcement made on 25 March 2020.

The Genedrive® 96 SARS-CoV-2 assay combines Genedrive's PCR chemistry integrated with Cytiva's LyoStable® stabilisation technology. The combination would allow for high throughput manufacturing of over 10,000 tests per hour in a 96-well, temperature-stable plate format that could be transported globally without the need for refrigeration. The one-step test features a single PCR bead that once mixed with a patient's sample, can be performed on a variety of existing open PCR platforms from manufactures such as Roche and ABI (Thermo Fisher). Further product details are available on the genedrive website at https://genedrive.com/assays/in-development-genedrive-96-sars-cov-2.php

As the global spread of coronavirus infection increases, it is likely that a variety of diagnostic tools will be needed for direct clinical care via specialist laboratories, central hospital labs and in the community. It is likely that millions of people will need to be tested, and high throughput PCR molecular testing will play a central role. Genedrive aims to deliver clinically verified, consistent and reproducible assays that are easy to use and can be manufactured and delivered globally in high volume. Working with Cytiva will help us achieve this goal.

David Budd, Chief Executive Officer of Genedrive plc, says: "We have extensive experience working with the Cytiva team on assay development and manufacturing for our Point of Care HCV, AIHL, and military programmes. We are pleased to now apply that partnership in a high throughput manufacturing process, which we believe places us amongst a small group of companies that have the capability to produce simple assay solutions at significant scale. We are working very aggressively and plan to have product available in the next five weeks."

Gabriel Fernandez de Pierola, General Manager, Genomics and Diagnostics at Cytiva, says: "The spread of the SARS-COV-2 virus is driving an urgent need for extensive testing, particularly amongst patients and health workers. Critical to overcoming the pandemic is being able to produce high volumes of reliable tests which can be shipped easily on a global basis with minimal environmental impact. We hope our Lyo-Stable technology coupled with Genedrive's high throughput testing solution will help deliver technical solutions to address the current crisis."

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 Genedrive® mt-RNR1-ID kit has received CE-IVD Certification and will be launched into Europe and other markets following full evaluation by the UK National Health Service. 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, based on Genedrive PCR chemistry.

About Cytiva

Cytiva is a 3.3 billion USD global life sciences leader with nearly 7,000 associates operating in 40 countries dedicated to advancing and accelerating therapeutics. As a trusted partner to customers that range in scale and scope, Cytiva brings speed, efficiency and capacity to research and manufacturing workflows, enabling the development, manufacture and delivery of transformative medicines to patients. Visit www.cytiva.com for more.