24th Oct 2014 07:08
LONDON (Alliance News) - Omega Diagnostics Group PLC Friday lowered its expectations for its full-year financial performance, as it does not expect to see any revenue from its Visitect CD4 rapid test for HIV due to setbacks, although it reiterated confidence in the product's future prospects.
Shares in Omega Diagnostics are trading down 27% at 14.01 pence at the market open Friday.
The medical diagnostics company said its first half to end-September trading is in line with its expectations, with pretax profit before acquisitions costs, share payments, and amortisation to be around GBP560,000, ahead of GBP430,000 a year before.
Revenue is expected to be GBP5.69 million, up slightly from GBP5.6 million a year before, with the strength of sterling reducing revenue by around GBP250,000.
The company said its future growth continues to be strongly influenced by the prospects of Visitect. During the period, the company said it saw a sub-optimal performance in its Kenyan evaluation of CD4, and said it was yet to "determine the root cause" of this.
At the moment, the Kenyan trial investigator has agreed that once product becomes available, Omega will have access to facilities in Kenya to demonstrate an "acceptable" performance of the test on 100 patients, after which it will repeat the original 200 patient evaluation. The earliest this will happen is likely to be late January, Omega said.
It has also been working to see comparable results between finger-prick and venous blood samples on the test; it has seen variable results which means it will need to undertake further investigative work.
Omega said that whilst "it is not uncommon that issues are discovered as one moves from small batch production to large-scale manufacturing, these are certainly frustrating events for both management and shareholders."
It will need to resolve these issues ahead of the launch of the product into the market, but Omega reiterated confidence that the product will be "a major success."
"We will, however, continue to operate in an environment of timing uncertainty until we resolve the issues we face, and evaluations lead to full market acceptance of the product," the company said in a statement.
Away from this product, Omega said it had made good progress with its allergy development programme, having developed a further eight allergens for use with Immunodiagnostic Systems Holdings PLC's IDS-iSYS automated analyser. This takes its total to 16 allergens. It said it has completed the transfer of on-going optimisation work from its external contract to its in-house team, and completed optimisation on 11 allergens.
By Hana Stewart-Smith; [email protected]; @HanaSSAllNews
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