The Courier & Advertiser (Fife Edition)
Milestone for Omega’s flagship HIV test
Shares in Omega Diagnostics jumped in early trading yesterday after the medical group said it had reached a “key milestone” in the development of its hand-held HIV test kit.
The company’s flagship CD4 HIV indicator has been hit by a series of delays during its development, the latest of which was an ambient temperature anomaly.
However, the Alva-based company said it had selected a new design for the CD4 unit and testing at varying temperatures on over 100 HIV positive samples at a UK hospital had uncovered no further ambient temperature issues.
In addition, the company said more than 400 other samples were tested by non-Omega staff at two further UK sites and the data from all three programmes had fallen within expected boundaries.
“Accordingly, the product has reached a key milestone whereby we have now entered formal design control,” the firm told investors.
“To support this process, we have recently recruited an experienced project manager who is now leading this selected test design through optimisation to ensure we can achieve manufacturing robustness and scalability.
“Thereafter, we plan to manufacture batches of devices for external field trials and to complete the claim support work required for CE-Marking.”
Omega also said it had secured its first order for lead allergen test product and said its new rapid test manufacturing site in India had been recommended for a commercial production licence.
The company added that it was on track to hit financial targets at the half year stage.
Shares in Omega closed up 0.50 at 18.75 following trading yesterday.