(Alliance News) - Omega Diagnostics Group PLC said Friday its technology partner, Mologic Ltd, has filed its submission to the US Food & Drug Administration requesting emergency use authorisation for its Covid-19 antigen test.
The test will be used under Omega's Visitect brand and Global Access Diagnostics brand.
Omega Chief Executive Colin King said: "We are very pleased that the regulatory process to make our Visitect Covid-19 antigen test available in the US professional use is progressing well.
"We believe we have a high-quality, high-performance product with significant global appeal and the US market, due to both its size and high barriers to entry, would be a very attractive commercial market for our product."
Mologic completed the performance studies needed for the test to achieve regulator approval for professional use in the US in early June.
It also seeking a CE mark for the test to become available in Europe.
Shares in Omega were 4.6% higher in London on Friday morning at 56.50 pence each.
By Paul McGowan; paulmcgowan@alliancenews.com
Copyright 2021 Alliance News Limited. All Rights Reserved.
