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Omega Diagnostics' COVID test rejected for sale in UK; shares fall


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.

Reuters - March 12, 2022

View the full story here: https://www.reuters.com/business/healthcare-pharmaceuticals/omega-diagnostics-covid-test-rejected-sale-uk-shares-fall-2022-03-11/