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Omega Diagnostics (ODX) Files FDA Submission For Covid-19 Test, Shares Gain

Updated: 2 Jul 2021

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.

Should you invest in Omega Diagnostics shares?

Omega Diagnostics shares are traded on the London stock exchange's AIM market (the alternative investment market), which is the submarket specifically for smaller companies. AIM stocks are attractive to investors as they have tax advantages and smaller companies have the potential to benefit from rapid growth. But are Omega shares the best buy? Our stock market analysts regularly review the market and share their picks for high growth companies

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