Omega's professional-use Covid test rejected by UK regulator

11th Mar 2022 16:10

(Sharecast News) - Omega Diagnostics announced another disappointment for its Covid-19 tests on Friday, announcing that the UK Health Security Agency said its application for approval of the professional-use 'VISITECT' antigen test under the Coronavirus Test Device Approvals regulations (CTDA) was unsuccessful.

The AIM-traded firm said as a result, the product would not be available for sale in the general UK market.

It said some supporting data provided by third-party development partners, submitted for the desktop review, used comparator 'RT-qPCR', or quantitative reverse transcription PCR, results from studies conducted in late 2020 and early 2021, which pre-date the CTDA regulations.

Some of these comparator tests were not CE-marked, or did not meet the sensitivity and specificity requirements of the CTDA.

Those results thus had to be excluded from the review and, as a result, there were insufficient test results to meet the CTDA requirements.

Currently, with insufficient demand for the professional-use test, the company said it did not plan to commission further studies.

Its board said it believed the self-test market was "much more relevant" in terms of opportunity, as the company worked with its external study centres to ensure the 31 March deadline was met for the submission of the outstanding self-test CE-mark data.

"Whilst this is clearly disappointing, our plans do not include any contribution from Covid-19 antigen tests, as we focus the business on driving growth in our health and nutrition division," said chief executive officer Jag Grewal.

At 1537 GMT, shares in Omega Diagnostics were up 1.93% at 4.23p.