OMEGA Diagnostics has hailed a “key milestone” in the delivery of coronavirus test kits after securing European approval.
The Alva-based biotech firm expects to have an initial AbC-19 Rapid test production capacity in place in September to produce 100,000 tests a week scaling up to 200,000 tests weekly in October.
Following on from the announcement in June confirming design-freeze, Abingdon Health Limited, as lead partner of the UK-RTC, has now confirmed that it has CE-Marked the AbC-19 Rapid test for professional use.
The company is currently transferring the manufacturing process from Abingdon Health Limited to its Alva facility and expects to the capability to manufacture at scale by the end of August.
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The UK-RTC consortium said the antibody test achieved the CE mark by meeting Medicines and Healthcare products Regulatory Agency stipulations, adding: “The test is now available for distribution for use by professionals.”
To achieve self-testing accreditation, a usability study will be performed by Ulster University using 2,000 volunteers and once complete will allow the UK-RTC to seek final approval from the MHRA for self-test use. The test will also be subject to further independent evaluation.
Omega said 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.
The antibody test determines whether an individual has previously been infected, while antigen tests confirm the presence of the virus.
Colin King, Omega chief executive, said: “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.” The UK-RTC was formed in April when Omega signed a memorandum of understanding with Abingdon Health Limited, BBI Solutions Limited, CIGA Healthcare Limited, in conjunction with the University of Oxford.
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