Design freeze of COVID-19 lateral flow antibody test
Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance notes the Press Release issued today by UK Rapid Test Consortium (“UK-RTC”) on developing a COVID-19 lateral flow antibody test (“COVID-19 Rapid Test”) that can be used by people in their homes.
As announced on 9 April 2020, the Company signed a Memorandum of Understanding (“MOU”) with Abingdon Health Limited, BBI Solutions Limited, CIGA Healthcare Limited, in conjunction with the University of Oxford to form the UK-RTC in order to jointly develop and manufacture a COVID-19 Rapid Test as part of the Government’s five pillar national testing strategy for COVID-19.
Abingdon Health Limited, lead partner of the UK-RTC, has informed consortium members that it has attained design freeze for the COVID-19 Rapid Test. The next stage is for Abingdon Health to complete verification, validation, transfer the manufacturing protocols to consortium members and gain regulatory approval.
The transfer of the manufacturing process to Omega will enable it to undertake its own validation work to prove equivalent performance and to demonstrate the test can be manufactured at scale to meet the UK Government’s demand. These activities will commence immediately, and the Company expects to complete this work by the end of August. Initially it is the Company’s plan to produce 100,000 tests per week scaling up to 200,000 tests per week by the end of September. Based on demand for its wider COVID-19 test portfolio, Omega has flexibility in the utilisation of its overall manufacturing capacity so that more could be allocated to the UK-RTC if required.
The UK-RTC Press Release is provided in full at the end of this announcement.
Colin King, CEO of Omega commented: “This key milestone achievement in such a short timescale is a credit to the hard work put in by the consortium, especially Abingdon Health. 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.”
The information communicated in this announcement is inside information for the purposes of Article 7 of EU Regulation 596/2014.
Press Release from UK-RTC (issued on 29 June 2020)
The UK-RTC is delighted to announce that it has reached design freeze for the AbC-19 ™ lateral flow test for IgG antibodies to the SARS-COV-2 virus (COVID-19). Achievement of this major milestone means that the test meets the required performance characteristics and the production specifications of the assay have now been set. The next stage will see the scale-up of processes in July in readiness for manufacture.
With regards to the test performance, an evaluation of pilot batch products showed a test sensitivity of 100% (95% confidence interval 92.6% to 100%) and specificity of 98.4% (95% confidence interval 95.4% to 99.7%). These figures have been calculated following analysis of a total of 186 samples taken from individuals pre-September 2019 (negatives) and 48 patients who had symptoms of COVID19, a positive PCR result for the virus or both. Results are from analyses performed at the University of Ulster and Abingdon Health laboratories and follow an earlier analysis at Imperial College, London of 188 positive samples using pre-design freeze devices which showed a 95.7% sensitivity.
If the population is assumed to have a 10% incidence of COVID19, the AbC-19 pilot batch test shows a 98.6% accuracy.
Additional independent testing of positive and negative samples along with other analytical studies will allow CE marking. Work is continuing in parallel with the regulatory authorities to ensure approval of the test as quickly as possible.
This is a major step forward in an extremely complex project that has been completed in a very short time period compared to a normal test development programme. The UK-RTC has been committed to delivering this vital test to the UK public, to assist in the management of COVID-19 infections and aid further understanding of the disease
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