Omega Diagnostic (LON: ODX) said on Friday that its technology partner, Mologic, has filed its submission to the US Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its Covid-19 antigen test.
The test will be used under Omega’s VISITECT and Global Access Diagnostics (GAD) brands.
Colin King, CEO of Omega, commented: “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.”
At the beginning of June, the company revealed it was in the process of seeking CE marking for the rapid point-of-care antigen test to be sold for home use in Europe by late July.
Omega Diagnostics share price is currently up 3.43% at 55.85p, below the 59p highs seen earlier in Friday’s session.
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