FDA Approval1 Jul 2021 12:02
With all the nonsense going on with the UK government, it's easy to forget that there's potentially a huge market in the USA & Europe for Omega diagnostics/Mologic's VISITECT® brand LTF, which is in the final stage for FDA approval.
Hold for gold, as they say.
Regulatory approvals
Omega announces that it has begun the process of engagement with its European Notified Body seeking CE marking of
the VISITECT® COVID-19 Antigen test, a rapid point-of-care diagnostic test for the detection of active COVID-19
infections as a self-test. The Company is agreeing the protocols required for utilisation studies and will update
shareholders as this process progresses. The test is already CE marked for professional-use and the Company is
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.
The Company also announces that its technology partner, Mologic Ltd (“Mologic”) has successfully completed the
necessary performance studies required for regulatory approval in the US and is now in the final stages of preparing a
submission to the U.S. Food and Drug Administration (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
brand.