13th Feb 2014 09:24
LONDON (Alliance News) - Omega Diagnostics Group PLC said Thursday that it had completed its CD4 technology transfer project, having successfully completed a three-batch validation of its manufacturing protocol.
The medical diagnostics company has been undertaking a number of experiments to investigate variability within the production process to select a single preferred manufacturing protocol.
CD4+ T-cells are destroyed by the HIV virus, so monitoring their count is important for the management of HIV patients being treated by antiretroviral drug therapies.
Omega produces Visitect CD4, a disposable, semi-quantitative rapid test for the determination of CD4 counts in whole blood.
Omega said that the results from tests on patient samples using the second and third batches showed that Visitect meets design parameters of clinical sensitivity, specificity, accuracy and reproducibility.
Now that this project is completed Visitect is ready for full in-country field evaluations; the first of which are expected to begin in March in Kenya and Mozambique.
Shares in Omega were trading up 15% at 19.20 pence Thursday morning.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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