Omega Diagnostics says test not yet approved in UK under new regulations

Omega Diagnostics (LON:ODX) is the latest COVID-19 test manufacturer to announce that its lateral flow test has not yet been approved under the UK Health Agency’s new Medical Devices regulations that came into force on 1st November.

The UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations require all suppliers of COVID-19 tests to submit information regarding their products for desktop review if they wished for their products to remain on sale in the UK when the regulations came into force.

Omega Diagnostics’ VISITECT test has already received the CE Mark for professional use but the new regulations go over and above the requirement for the CE Mark. The AIM-listed diagnostics company said it submitted all the documentation ahead of the deadlines and paid the necessary fee, however, the test has yet to be approved under the new regulations and therefore cannot currently be sold in the UK.

Omega is not the first publicly traded company to fall foul of the new regulations. Yesterday, Avacta Group (LON:AVCT) said they had also had to pull their test from sale, despite submitting all the relevant documentation in time.

Omega said that the setback is not expected to cause a delay in the supply of Omega’s VISITECT professional-use COVID-19 antigen test to DAM Health clinics in the UK under the agreement announced on Monday.

At 09:01BST, Omega Diagnostics shares were trading lower by 2.6% at 47.48 pence per share.