Omega Diagnostics (ODX) said a submission has been filed to the US FDA requesting Emergency Use Authorization (EUA) for its rapid point-of-care COVID-19 antigen test for use under both the Omega's VISITECT® brand and Global Access Diagnostics (GAD) brand. 

The medical diagnostics company focused on CD4, infectious diseases and food intolerance said the submission, which follows the completion of the US performance studies, was made by its technology partner and developer of lateral flow and rapid diagnostics, Mologic Ltd. 

Omega announced in early June 2021 that it was making progress to gain regulatory approval for its VISITECT® COVID-19 antigen test as a self-test product and for US professional use. 

At the time, the company said it had already initiated the process of engagement with its European Notified Body to seek a CE mark for its rapid point-of-care diagnostic VISITECT® COVID-19 antigen test for the detection of active COVID-19 infections as a self-test. 

Omega also added that it was in the final stages of preparing a submission to the U.S. FDA requested Emergency Use Authorisation (EUA) for the rapid point-of-care COVID-19 antigen test, for use under both its VISITECT® brand and Global Access Diagnostics brand.

Shares in Omega Diagnostics have shed around 15% in value since the beginning of 2021. Following the confirmation of its submission to the US FDA, shares were trading 3.7% higher.

Today, that regulatory process has now been achieved. Speaking of the submission, CEO, Colin King, said, "We are very pleased that the regulatory process to make our VISITECT® COVID-19 Antigen test available in the US for professional use is progressing well.”

He added, “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."

Omega’s test is already CE marked for professional-use and the Company is now targeting approval by the end of July to allow the test to be sold in Europe for home-use as well. 

As the global market for antigen testing develops the Company believes self-test approval will be a key product differentiator, as has already been seen in the UK, it told investors. 

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