OMEGA Diagnostics has seen its shares rise 16% after confirming it is ready to start field trials of its much anticipated HIV testing product.
The business, which has its headquarters in Alva, Clackmannanshire, said the Visitect CD4 kit is likely to be used in Kenya and Mozambique next month.
It comes after a long process to perfect the manufacturing protocol but Omega indicated it was happy it now has a system in place which "meets the design parameters of clinical sensitivity, specificity, accuracy and reproducibility".
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As well as the field tests the AIM listed company will move towards securing a CE-Mark for CD4, which is based on technology developed by the Burnet Institute in Melbourne, Australia, in the next few months.
The kit is used to find out if the white blood cell count of an HIV patient has fallen to a level where retroviral drug treatment is needed. It does this quickly and without the need to send material to a laboratory.
Analysts have estimated annual sales could be as much as £2 million by 2015 with the test attracting interest from non-governmental organisations in developing countries as well as other life science companies. It has been suggested Omega could manufacture up to seven million kits annually.
The company has previously stated it would need to effectively double its Scottish workforce to more than 60 people if the CD4 and a separate range of allergy related products sell as well as expected.
Keith Redpath, analyst at Finncap, said the validation of the CD4 manufacturing process was a "significant milestone" towards commercialisation.
He retained a 25p price target on the stock and added: "Omega has successfully overcome multiple technical challenges to reach the point of full-scale production and very near-term commercial reality.
"We continue to believe that Omega remains ahead of competing developments in the arena of practical instrument-free [point of care] CD4 testing."
Andrew Shepherd, chief executive of Omega, said: "This now unlocks the full potential of Visitect CD4 which is eagerly awaited by the market."
Shares closed up 2.75p at 19.5p.