Omega Diagnostics’ Application for its COVID-19 Test Rejected by UK

UK-based Omega Diagnostics said its application to the UK Health Security Agency for approval of its professional-use Visitect COVID-19 antigen test was unsuccessful.

The company said that some supporting data provided by third-party development partners from studies conducted in late 2020 and early 2021 used tests that did not have a CE mark or did not meet the UK’s sensitivity and specificity requirements.

Omega Diagnostics said it will no longer seek approval for the professional-use COVID-19 antigen test but will instead focus on getting an at-home version of the test approved in the UK.