ODX.L Regulatory News (ODX)

OMEGA DIAGNOSTICS GROUP PLC

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

Update on VISITECT® CD4 Advanced Disease

Conclusion of Expert Review Panel for Diagnostics for VISITECT® CD4 Advanced Disease

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces that, following the conclusion of a quality risk assessment review by the Expert Review Panel for Diagnostics ('ERPD'), The Global Fund has informed the Company that its VISITECT® CD4 Advanced Disease test will be included in The Global Fund procurement list. This means that VISITECT® CD4 Advanced Disease tests may be procured by organisations with access to The Global Fund or UNITAID funds, following a review of procurement requests and the issue of a No-objection letter from the Global Fund.

The Global Fund requires the Company to submit its VISITECT® CD4 Advanced Disease test for WHO Prequalification review in order to reach prequalification before the end of the ERPD authorised period which runs to 11 September 2020. The Company confirms that it has already submitted the product to the WHO Prequalification review process.

Colin King, CEO of the Company, said: "I am delighted that we have received this response from ERPD that allows procurement access to our VISITECT® CD4 Advanced Disease test in certain circumstances and we look forward to providing a unique test to organisations which can help improve the health outcomes of many people living with HIV."

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

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