By Kristy Dorsey

OMEGA Diagnostics has moved into the next phase of work that will lead to the production of hundreds of thousands of Covid-19 testing kits starting from the end of August.

The Scottish medical diagnostics firm is part of the UK Rapid Test Consortium (UK-RTC) which has now achieved “design freeze” on the development of an antibody test strip that can be used at home to confirm whether someone has previously had the disease. It is hoped that such tests will provide guidance on whether individuals have developed a degree of immunity to novel coronavirus.

Design freeze is the stage at which development stops, allowing a project to move on to verification and validation of the product. In the case of the UK-RTC, this means that project leader Abingdon Health of York is passing on the manufacturing protocols for the rapid at-home testing kit to other members of the consortium.

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They include Clackmannanshirebased Omega along with BBI Solutions, CIGA and the University of Oxford. Their combined output is expected to reach 50 million tests annually.

Omega said it has started its own validation work with immediate effect to demonstrate that it can produce the test at volume to the same standards as that of Abingdon’s pilot test batch, which showed 100% sensitivity across samples from 186 individuals. This work is expected to be completed by the end of August.

From there, Omega expects to begin production at an initial level of 100,000 tests per week, rising to 200,000 per week by the end of September. Based on demand for its wider Covid-19 test portfolio – which includes projects from a separate partnership with Mologic – Omega said it could allocate additional capacity to the UK-RTC if required.

READ MORE: Omega welcomes rapid testing progress

Chief executive Colin King praised the speed of progress on the project, which was first revealed on April 9 when Omega announced that it had signed a memorandum of understanding (MOU) to jointly develop the kit as part of the Government’s five pillar national testing strategy for Covid-19.

“This key milestone achievement in such a short timescale is a credit to the hard work by the consortium, especially Abingdon Health,” Mr King said. “We can now look forward with greater confidence in bringing this important test to market to support the UK and devolved governments in their fight against this pandemic.”

Volume manufacturing will be based at Alva headquarters of Omega, which has been re-shaping its business strategy as a result of the coronavirus outbreak.

The AIM-listed company, which makes tests to detect a range of infectious diseases and food intolerance, announced on June 9 that it would halt further development of new allergy products to focus on areas where it can achieve better returns. It will, however, continue production of 69 existing allergens to meet ongoing demand from Immunodiagnostic Systems, its commercial partner on this front.

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The decision to halt allergen production will result in an £8.7 million impairment charge.

“The decision to stop the development of further allergens has not been taken lightly but we recognise we can achieve better returns from directing our development efforts in other areas and we look forward to providing further updates as the opportunities we have in front of us deliver on their undoubted potential,” the company said at that time.

Omega’s other Covid-19 collaboration, a partnership with Bedfordshire-based Mologic, covers four further testing opportunities. This includes the production of laboratory-based kits to detect infection which are being produced from Omega’s facility in Littleport, Cambridgeshire.

The company announced on June 19 that it was raising up to £10.5m through a combined placing and open offer of new shares priced at 40p each. The proceeds will be used to scale up manufacturing and exploit further opportunities for Covid-19 testing, while also undertaking additional work on its Visitect CD4 products in the field of HIV.