Omega Diagnostics (ODX)  has noted the announcement today by the UK Rapid Test Consortium ("UK-RTC"), that the lateral flow COVID-19 Test has received CE marking. 

Omega is a is a partner of the "UK-RTC" and has played a key part in the design and development of of COVID-19 lateral flow antibody test (the "AbC-19™ Rapid test") using its expertise from products such as the CD4 lateral flow test. 

The CE-Marked the AbC-19™ Rapid test for professional use announcement follows the announcement on 29 June 2020 confirming design-freeze. 

Next Steps 

To achieve self-testing accreditation, pre-approval from the MHRA is required to perform self-test usability studies.  

The planned study will be performed by Ulster University using approximately 2,000 volunteers and, once complete, will allow the UK-RTC to seek final approval from the MHRA for self-test use. In addition, the test will also be subject to further independent evaluation. 

The UK-RTC has now confirmed it is currently transferring the manufacturing process from Abingdon Health Limited to Omega’s Alva facility and expects to complete the work to prove equivalent performance and the capability to manufacture at scale by the end of August.  

Omega plans to have an initial AbC-19™ Rapid test production capacity in place in September to produce 100,000 tests per week scaling up to 200,000 tests per week capacity in October.  

If demand through the UK-RTC was to go above 200,000 tests per week, either from the UK Government, or from other third parties, the Company would allocate additional capacity to meet that demand as well. 

Shares in ODX have performed strongly over the past three months, from lows of 33p during the height of the COVID-19 crisis, to trading up 7% today following this announcement. 

Colin King, CEO of Omega, commented: "I am delighted that our consortium partner, Abingdon Health has delivered another key milestone as promised and it is even more impressive that this has been achieved within such a compressed timeline to meet very stringent technical requirements set by the MHRA. Omega is focused on ensuring it completes the technical transfer in a timely manner and plays its part in the fight against this pandemic." 

Omega Diagnostics is a key component of the Vox Markets COVID-19 index that can be seen here : https://www.voxmarkets.co.uk/index/vox-covid-19/