SHARE in Omega Diagnostics tumbled today after the life sciences firm suffered a fresh setback for its testing kit that checks the immune systems of HIV patients.
The Alva-based firm has moved the manufacturing of its Visitect CD4 device in-house after field trials in Kenya last year revealed “just below optimal performance”.
Omega has said it is “very confident” about the commercial success of the product, which aims to determine when HIV sufferers will need to take anti-retroviral drugs to bolster their immune systems. However, the firm said yesterday that it has discovered an issue with the longer-term stability of the kit while stored at room temperature.
Edward Valente, the group’s research and development director, told The Scotsman that the issue could take at least three months to resolve before the firm looks to resume field trials.
“We didn’t expect to see what we saw – something’s not working and the test signal is indicating that more people would need treatment than actually do. We don’t know the cause, so we need to set up experiments to identify what the problem is.”
The setback, which pushed Omega’s shares down as much as 24 per cent, came as the company reported a better-than-expected 25 per cent jump in adjusted pre-tax profits to £1.37 million for the year to 31 March.
The kits are being made in Alva, where the Aim-quoted firm employs about 40 people, but Omega is also working on a manufacturing facility in India to avoid being hit by hefty import duties, and the site is expected to be complete within six months. Once up and running, the plant will be able to produce two million tests a year, on top of the 2.5 million made in Alva.
Finance director Kieron Harbinson said it was “not impossible” that commercial sales of the device could begin next year, as previously predicted by analysts at house broker FinnCapp.
He added: “We absolutely remain upbeat – we’ve made a lot of significant progress over the last seven months in solving what was previously a variability issue. While the stability issue is disappointing, the fact that all batches showed the same level of drop-off is a small positive in an otherwise negative.
“We’ve risen to many challenges before with CD4 and overcome every one of them, and we’re confident we’ll overcome this one.”
Turnover at Omega rose 4 per cent to £12.1m amid a strong performance for its food intolerance products.
Chief executive Andrew Shepherd said: “However, we all appreciate that the focus is on Visitect CD4 as this product has the ability to be truly transformational for the group.”