Sit Back, Relax and Wait11 Aug 2020 15:10
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 Company is currently transferring the manufacturing process from Abingdon Health Limited to its Alva facility and expects to complete the work to prove equivalent performance and the capability to manufacture at scale by the end of August.