(Reuters) – Omega Diagnostics Group Plc said on Friday its COVID-19 antigen test kit had not been approved by the UK health security agency and the product would not be available for sale in the country, sending its shares tumbling more than 20%.
Late last year, a new review system came into force under which COVID-19 test suppliers had to submit information on comparator tests for their products for a “desktop review” if they wished to remain on sale in Britain.
Omega said some data submitted before the new review had to be excluded in the latest evaluation, as they did not meet the sensitivity requirements, leading to insufficient data for an approval. It added that no further tests were planned at this time.
“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 & Nutrition division,” Chief Executive Officer Jag Grewal said.
The medical diagnostics company also said the self-test market was “much more relevant in terms of opportunity” and it was working with external study centres to meet a March 31 deadline for the submission of self-test data under European regulations.
Shares in Omega Diagnostics pared some losses to trade 9.6% lower at 3.75 pence as of 0827 GMT.
(Reporting by Siddarth S and Pushkala Aripaka in Bengaluru; Editing by Rashmi Aich)
