Scottish life sciences firm Omega Diagnostics has hailed a breakthrough in the development of its flagship HIV test.
The Alva-based outfit has spent the past four months trying to identify and eliminate an anomaly that arose during pre-production of its CD4 test.
The product has sparked international interest as it has the potential to identify those at heightened risk of having the AIDS pre-cursor virus through a simple pinprick blood test with an almost immediate outcome.
It is expected the test could prove extremely useful in remote areas and in third world communities around the globe where access to mainstream healthcare is a major issue.
AIM-listed Omega, which also has interests in the allergy, food intolerance and infectious diseases fields, yesterday said it had made significant progress in eliminating the “technology transfer” issues experienced during production of the CD4 test.
“As reported last month with the interim results, we selected a preferred manufacturing protocol to proceed to a three-batch validation,” Omega said in an update to the markets yesterday.
“The company is pleased to announce that it has produced a first reference batch which, when tested on patient samples, has produced results which are within the agreed design specification for the accuracy of the test and which demonstrate a significant reduction in the levels of variability previously reported.
“This is an important milestone in the technology transfer project and we will proceed to test the protocol with further independent manufacturing runs.
“The board has increased confidence in successfully completing the three-batch validation and, given the proximity to Christmas, we will provide a further update early in the New Year.”
Despite the delays, the firm has previously said it expected both CD4 and its latest generation allergy test IDS-iSYS to be earnings enhancing in the coming financial year.
Analyst Keith Redpath of house broker finnCap yesterday said the production milestone was “pivotal result” for the company.
“Two further batches will need to be tested on patient samples and if they also meet the predetermined specification, then Omega will have a robust manufacturing process for the diagnostic,” Mr Redpath said.
“The results from this first batch increase our confidence that the technology transfer is nearing a successful conclusion.
“Completion of the technology transfer and manufacturing scale up would enable Omega to supply product for field trials.”
The update gave some pre-Christmas cheer to investors yesterday and shares in Omega closed the day up 1.38% at 18.75p.