Omega Diagnostics up on CE-marking of Covid test
Omega Diagnostics updated the market on the work of the UK Rapid Test Consortium in the development of a Covid-19 ‘Abc-19’ lateral flow antibody test on Thursday, reporting that lead partner Abingdon Health has CE-marked the test for professional use.
The AIM-traded firm said that, to achieve self-testing accreditation, pre-approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) was required to perform self-test usability studies.
It said the planned study would be performed by Ulster University using around 2,000 volunteers and, once complete, would allow the consortium to seek final approval from the MHRA for self-test use.
In addition, the test would also be subject to further independent evaluation.
Omega said it was currently transferring the manufacturing process from Abingdon Health to its Alva facility, and expected to complete the work to prove equivalent performance and the capability to manufacture at scale by the end of August.
The company was planning to have an initial AbC-19 test production capacity in place in September to produce 100,000 tests per week, scaling up to 200,000 tests per week in October.
If demand through the consortium was to go above 200,000 tests per week, either from the UK government or from other third parties, Omega said it would allocate additional capacity to meet that demand as well.
“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,” said chief executive officer Colin King.
“Omega is focused on ensuring it completes the technical transfer in a timely manner and plays its part in the fight against this pandemic.”
At 1105 BST, shares in Omega Diagnostics Group were up 3.2% at 62.95p.