Omega Diagnostics progresses Covid-19 test with EU, US regulators

(Sharecast News) - Medical diagnostics company Omega updated the market on regulatory approvals for the 'Visitect' Covid-19 antigen test on Tuesday, confirming that it has started engaging with its European notified body, seeking CE-marking of the test.
The AIM-traded firm described Visitect as a "rapid, point-of-care" diagnostic test for the detection of active Covid-19 infections, used as a self-test.

It said it was currently agreeing the protocols required for utilisation studies, and would issue updates as that process progressed.

The test was already CE-marked for professional use, with Omega 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 developed, the company said it believed self-test approval would be a "key product differentiator", as had already been seen in the UK.

Omega also announced that its technology partner Mologic had successfully completed the necessary performance studies required for regulatory approval in the United States, and was now in the final stages of preparing a submission to the US Food and Drug Administration (FDA) requesting emergency use authorisation (EUA) for its rapid point-of-care Covid-19 antigen test, under both the Omega's Visitect brand and the 'Global Access Diagnostics' brand.

"I am pleased with the progress we are making to gain regulatory approval, both for our VISITECT self-test product and for US professional use," said chief executive officer Colin King.

"Both routes offer potentially significant opportunities as we believe we have a high quality product with global appeal."

At 0909 BST, shares in Omega Diagnostics were down 0.41% at 60.25p.