Omega Diagnostics Gp (ODX.L) CE-Mark: Mologic COVID19 lateral flow antigen test

Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance, announces that it has CE-Marked Mologic Ltd’s (‘Mologic’) lateral flow antigen test for COVID-19, to be sold for professional-use under Omega’s VISITECT® brand. The test will provide healthcare professionals with an accurate rapid test for the detection of the nucleoprotein of the SARS-CoV-2 virus in respiratory swabs.

Having commenced technology transfer late last year Omega has CE-marked the product and is now in the process of completing marketing launch for commercial roll-out which is expected to start in April. The Company is already in discussion with a number of potential commercial partners looking to order the test post launch.

The Company is well on its way to establishing a lateral flow production capacity of approximately 2 million tests per week by the end of April from its Alva facility in Scotland. This production capacity will be used to produce this VISITECT® branded antigen test for sale to third-party commercial customers.

The Company’s production capacity will be used to fulfil demand across a range of lateral flow tests:

· VISITECT® CD4 Advanced Disease test – a rapid, semi-quantitative lateral flow assay used in the treatment of patients living with HIV

· VISITECT® branded COVID-19 lateral flow antigen tests – now CE marked and being launched in April as noted above

· COVID-19 Lateral flow antigen tests – under contract for the UK Government (as announced on 11 February 2021)

· VISITECT® COVID-19 IgM/IgA/IgG – a rapid test for the detection of three antibody isotypes to SARS-CoV-2

· AbC-19TM COVID-19 Rapid Antibody Test

Utilisation of the Company’s weekly production capacity for the supply of antigen tests under the DHSC contract, and the supply of the other tests above, is expected to have a significant impact on the future performance of the business and whilst volumes are unquantified it is likely to result in substantial revenue growth in the financial year beginning 1 April 2021.

Colin King, CEO of Omega, commented: “This is an exciting and important next step in our COVID strategy as we now have the ability to supply both antigen and antibody lateral flow tests not only to the UK Government but also to our commercial partners. Having both tests available and having built our production capacity allows us to adjust our capacity to meet the demands of the pandemic. We look forward with confidence that the coming year ahead will be truly transformational for Omega.”

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

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