Shares of Omega Diagnostics (LON: ODX) are trading lower on Tuesday, despite a somewhat positive update on its VISITECT COVID-19 Antigen test regulatory approvals.
The AIM-listed firm said it has begun the process of engagement with its European Notified Body seeking CE marking of the VISITECT COVID-19 Antigen test.
Omega is currently in the process of agreeing on the protocols required for utilisation studies.
The test is already CE marked for professional use with Omega targeting approval by the end of July to be sold in Europe for home use.
“The Company believes self-test approval will be a key product differentiator, as has already been seen in the UK,” stated Omega.
Alongside the announcement, the company also revealed that its technology partner, Mologic, has completed the necessary studies required for regulatory approval in the US and is in the final stages of preparing a submission to the FDA requesting Emergency Use Authorization for its COVID-19 antigen test. It will be branded under both Omega's VISITECT brand and the Global Access Diagnostics brand if successful.
“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 Colin King, CEO of Omega.
“Both routes offer potentially significant opportunities as we believe we have a high-quality product with global appeal,” added King.
Omega's share price fell as low as 58.7p earlier in today's session. It is currently trading at 60p, down 0.83%.
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