ODX.L Regulatory News (ODX)

Omega Diagnostics Group PLC

("Omega" or the "Company")

CD4 Update - Successful completion of Technology Transfer

Omega (AIM: ODX), the medical diagnostics company focused on allergy, food intolerance and infectious disease, announces the successful completion of its CD4 technology transfer project with first in-field evaluations to start next month.

Further to the announcement made in December 2013 regarding the first reference batch, the Company announces that it has successfully completed a three batch-validation of its manufacturing protocol. The results from tests on patient samples with the second and third batches have demonstrated that Visitect® CD4 meets the design parameters of clinical sensitivity, specificity, accuracy and reproducibility.

This is a major milestone towards full commercialisation of the Visitect® CD4 test and accordingly, the product is now available for full in-country field evaluations. The first evaluations are expected to commence next month in Kenya and Mozambique. Separate claim-support studies are planned to CE-Mark the test which will take place over the next few months.

The devices for the second and third batches were assembled using the Company's Alva-based manufacturing facility which was built last year, and this completes the equipment validation process required under ISO 13485. Accordingly, the Company now has a fully validated production facility, currently capable of manufacturing over seven million devices per annum.

Commenting on the completion of technology transfer, Andrew Shepherd, CEO of Omega said: "We are delighted to have successfully completed the milestone of technology transfer for this innovative product. This now unlocks the full potential of Visitect® CD4 which is eagerly awaited by the market."

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