OMEGA Diagnostics has reported that its long-planned HIV-testing kit is performing in line with its design goals and if tests proceed as planned, it could become commercially available in 2018.

Profit for the year ending March 31 at the Alva-based medical diagnostics firm narrowed to £1.35m, on revenue up five per cent to £12.7 million, with 19 per cent growth in its food intolerance business, to £7.06m.

Chief executive Andrew Shepherd said its portable white-blood-cell counting kit, Visitect CD4, had overcome the latest in a lengthy catalogue of setbacks, after it resolved an issue relating to the product’s functionality at ambient temperatures.

“The new design is giving very encouraging results and all is going in the right direction,” Mr Shepherd said.

“What we have to do now is gather more data on live patient samples in HIV testing labs. The results that are coming in at the moment are looking very, very good, so the degree of confidence is rising pretty rapidly. I think we’ve got a test that now will do what it’s supposed to do.”

Analysts FinnCap said the move past the so-called ambient temperature effect was the “light at the end of the tunnel” for Visitect, and increased forecasts for FY 2017 to £13.8 million revenue, with pre-tax profit of £800,000 as the company invests in further growth.

Mr Shepherd said it would take around six months of testing to ensure the Visitect design is working effectively, before the company returns to field trials in India and Kenya. While that is proceeding, the company will progress validation and verification testing ahead of a possible commercial launch in 2018.

Visitect is an instrument-free device that uses a simple pin-prick blood test to calculate an HIV patient’s white blood cell levels. The kit – which has similarities with home pregnancy kits – can tell healthcare workers within 40 minutes if a patient requires retroviral drug treatment. Omega believes it can revolutionise the treatment of HIV in developing countries.

Mr Shepherd revealed that a price of $5 per test has already been established, with unit sales expected to be in the millions. It has been established that around 200 million of the tests would be required annually.

Highlighting that two competitors recently dropped out of the market, he said: “Currently, machines that run CD4 tests require electricity, training and placement in hospitals. We’ll be the only point of care test that’s instrument free that can be used in a resource-poor setting.”

In addition to its facility in Alva, Fife, the company last year opened a manufacturing facility in Pune, India, which is currently making devices for rapid malaria testing.

In its food intolerance business, its flagship products Genarrayt /Foodprint, for laboratory use, and its Food Detective, for use by nutritionists, have continued to grow in export markets, with the latter available in 75 countries.

Mr Shepherd said this largely protected the company from Brexit – which he added would not impact on the development of Visitect CD4.

“Brexit won’t impact CD4 reaching where it needs to go if we successfully complete the technical challenge,” he said. “We’re an export business, so when there’s a weaker sterling, that helps us. We also have risk mitigation in that three-quarters of our turnover is to countries outside the EU with growth opportunities in particularly in North America and China.

"We’re in reasonably good shape as we have a wide geographically perspective.”