Shares of Omega Diagnostics are declining Wednesday after the company said its VISITECT professional-use COVID-19 Antigen test has yet to be approved under new UK Health Security Agency Medical Devices Regulations 2021.
The Coronavirus Test Device Approvals (CTDA) is a new requirement over and above the requirement for the CE Mark. Other companies such as Avacta have also been impacted by the regulations and lack of approval.
The new CTDA regulations require all suppliers of Covid-19 tests to submit information regarding their products for desktop review before 31 October if they wish to remain on sale in the UK after this date.
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Omega said it submitted all documentation ahead of the published deadlines and paid the necessary fee. However, in line with the vast majority of available tests on the market, Omega’s test has yet to be approved under CTDA.
The company stated that the new legislation is not expected to cause a delay in the supply of Omega’s tests to DAM Health clinics in the UK under the agreement announced on Monday.
The news has seen Omega shares fall just over 3% to 46.65p.
Should you invest Omega Diagnostics shares?
Omega Diagnostics shares are traded on the London stock exchange’s AIM market (the alternative investment market), which is the submarket specifically for smaller companies. AIM stocks are attractive to investors as they have tax advantages and smaller companies have the potential to benefit from rapid growth. But are Omega shares the best buy? Our stock market analysts regularly review the market and share their picks for high growth companies
