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(R) CD4 meets the design parameters of clinical sensitivity, specificity, accuracy and reproducibility.
This is a major milestone towards full commercialisation of the Visitect(R) 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(R) CD4 which is eagerly awaited by the market.”