TheBiG schreef op 30 juli 2020 08:18:
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* CE Marking of COVID-19 lateral flow antibody test for professional use
* The AbC-19TM Rapid test shows a 99.40% accuracy
* Produce 100,000 tests per week scaling up to 200,000 tests per week capacity in October
MEGA DIAGNOSTICS GROUP PLC
("Omega" or the "Company" or the "Group")
Update on progress of UK-Rapid Test Consortium
CE Marking of COVID-19 lateral flow antibody test for professional use
Omega (AIM: ODX), the medical diagnostics company focused on CD4, infectious diseases and food intolerance, notes the press release issued today by the UK Rapid Test Consortium ("UK-RTC"), of which Omega is a partner, on developing its COVID-19 lateral flow antibody test (the "AbC-19™ Rapid test").
Further to the announcement on 29 June 2020 confirming design-freeze, Abingdon Health Limited, as lead partner of the UK-RTC, has today confirmed that it has CE-Marked the AbC-19™ Rapid test for professional use.
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. The Company 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.
The UK-RTC is reproduced in full at the end of this statement.