ODX.L Regulatory News (ODX)

OMEGA DIAGNOSTICS GROUP PLC

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

AGM Statement

Omega (AIM: ODX), the medical diagnostics company focused on Global Health (CD4 and COVID-19) and Health and Nutrition, will hold its Annual General Meeting ('AGM') today at 11am at Omega House, Hillfoots Business Village, Alva, Clackmannanshire, FK12 5DQ. Simon Douglas, Non-executive Chairman, provides the following update to shareholders ahead of the meeting:

As outlined in our Final Results statement in July, we are confident that the Company is well positioned for exciting growth, and this remains the case as we move into the second half of the year.

Our Health and Nutrition Division continues to show early signs of recovery towards pre-pandemic revenue levels, and we have a strategic plan in place to deliver substantial growth from this division, particularly given the opportunities we see in both China and the US.

In terms of our Global Health Division, we remain optimistic about the long-term prospects for the roll-out of our VISITECT® CD4 Advanced Disease test, the first and the world's only instrument-free point of care test for monitoring CD4 levels, essential for the effective management of advanced HIV. We have received excellent feedback from external clinical studies and evaluations in key countries and can see positive indications that long term funders are supporting the roll out of the Advanced Disease initiative. We therefore remain confident that the market potential for our product reaching 4m to 6m tests a year within the next three to five years, representing an opportunity to generate £12m to £18m in annualised revenues.

We also remain confident in delivering significant value from opportunities within the COVID-19 testing space. Our positive dialogues with the third parties introduced to us by the Department of Health and Social Care (DHSC) are advancing and we are optimistic that these will conclude successfully and positively impact on our H2 performance.

Regulatory approvals in the US and CE marking for self-test use for our VISITECT® COVID-19 Antigen test will provide the catalyst for sales opportunities. We recently announced submission for CE marking for self-test use and we are now waiting for our European Notified Body to complete the review of our submission. MHRA approval for sale in the UK is expected to follow soon after CE marking for self-test use is confirmed. The US Food and Drug Administration (FDA) is reviewing the Mologic submission for professional use for the same test, and we expect a positive outcome for both submissions.

Advancement towards further regulatory approvals and commercial progress for the AbC-19TM rapid test continues. We had hoped for further news to update shareholders with on this progress, however the prospects for this test have not changed and we still believe there is a significant opportunity for this COVID-19 antibody test.

The cash position of the Company remains healthy and we will provide a short update on trading for the six months ending 30 September 2021 in November. We look forward to updating shareholders on any further progress in the meantime.

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