OMEGA Diagnostics has had a major breakthrough with its flagship HIV-management kit now available for trade sales.

The Alva-based group saw shares climb more than eight per cent on the announcement, which follows successful performance evaluations in India and the UK.

The group has indicated that initial sales are likely to be modest, ahead of further regulatory approval.

Omega will now enter the World Health Organisation (WHO) prequalification process. This takes around one year, and if successful, the group will be able to sell into larger NGO (non-governmental organisations) and UN procurement programmes.

These markets are estimated to provide the company with the opportunity to sell millions of test kits.

Andrew Shepherd, chief executive officer of Omega, commented: “Early opportunities are likely to lead to modest sales during the next twelve months [and] we anticipate generating significant demand once we have completed all the regulatory hurdles. We look forward to providing the global health community with unique point-of-care tests which address a significant unmet need.”

Visitect CD4 has been in development for years and has faced a number of delays, most recently when tests indicated the product was not adequately functioning at ambient temperatures.

Having resolved that issue, the company moved into further clinical trials, the results of which have enabled it to gain CE (Conformité Européene) Marking, meaning it can be sold on a business-to-business basis within the European Economic Area.

CD4 could have a major impact on the treatment of HIV patients living in the developing world. The disposable product can be used at the point-of-care and enables field clinicians to prioritise the need for retroviral drugs in HIV patients.

It does this by measuring the level of CD4 cells. These are white blood cells which play a role in the maintenance of a healthy immune system. Carriers of the HIV virus are likely to have reduced CD4 counts.

A healthy individual will have a CD4 count somewhere between 500 and 1,500. If this falls below 200, the patient is deemed to have advanced HIV disease and is at risk of serious illness. The Visitect CD4 test enables clinicians in the field to establish if a person’s CD4 count is above or below 350.

Omega is currently working on another Visitect product which utilises a 200 count cut-off.

Analysts at FinnCap have estimated that that Omega has the capacity to produce 2.5 kits on a single shift basis. If market demand was at peak capacity, at a price of £4 per kit, it could generate £10 million in revenue for the group.

In its last financial year, Omega posted revenue of £14.2m. Interim results for the six months to September 30 are expected to show sales of £7.1m.

The group was founded by Mr Shepherd in 1987 and floated on the Alternative Investment Market in 2006.