ODX.L Regulatory News (ODX)

OMEGA DIAGNOSTICS GROUP PLC

("Omega" or the "Company" or the "Group")

Material Transfer Agreement signed with Mologic Ltd

COVID-19 antibody test

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases, food intolerance and allergy testing, announces that it has signed a Material Transfer Agreement ("MTA") with Mologic Ltd ("Mologic") to formalise a partnership to provide manufacturing capability for Mologic's COVID-19 first generation ELISA1 diagnostics test, the development of which has been funded in part by the UK government. Once ready, the antibody test will be capable of playing a key part towards identifying people that have built up immunity to coronavirus.

Omega has provided Mologic with access to one of its manufacturing facilities (which specialises in manufacturing ELISA tests), situated in Littleport, Cambridgeshire, England and both parties have collaborated to produce pilot batches and first validation batches.

The MTA formalises Omega's access to raw materials and know-how to manufacture Mologic's diagnostic test at scale, using Omega's ELISA manufacturing facility in Littleport.

Following successful independent validation of Mologic's ELISA test by the Liverpool School of Tropical Medicine and St George's, University of London, Mologic has now submitted its test to Public Health England and NHS Scotland for formal validation. Once validated, Omega and Mologic will enter into a longer-term supply agreement with Omega manufacturing up to 46,000 COVID-19 tests per day.

Omega will also CE Mark the test under the MTA, after which both parties will work together to commercialise the test.

The arrangement with Mologic is separate from, and additional to, the announcement made by the Company on 9 April 2020 relating to the UK Rapid Test Consortium (RTC), which is to jointly develop and manufacture a Point-of-care COVID-19 lateral flow antibody test which could be used 'at-home' and which will be manufactured in Omega's Alva facility in Scotland. Mologic's COVID-19 ELISA diagnostic test is also an antibody test but will be used on patient samples sent by hospitals or GPs for laboratory testing. In the current environment there is demand for both at-home and laboratory-based tests.

Colin King, CEO of Omega commented: "We are pleased that Omega has been able to support Mologic with the development and scale up of their ELISA test. This is another example of the UK diagnostics industry working in collaboration to bring effective solutions in the fight against this global pandemic."

The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.

1 ELISA (Enzyme Linked Immuno-Sorbent Assay) tests are one of the most tested and proven laboratory technologies used by the global diagnostic industry and remain the principle reference point from which rapid diagnostics are coordinated, especially serological tests, including tests for COVID-19.

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