By Samuel Indyk
Investing.com – Avacta Group (LON:AVCT) has suspended the sale of its AffiDX SARS-CoV-2 Lateral Flow Rapid Antigen Test in the UK following the introduction of new regulations. The UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 came into force yesterday which has forced Avacta to suspend sales.
Avacta will now suspend sales until the ongoing desktop evaluation of the test has been successfully completed by the Agency and the test is subsequently put on the CTDA register for approved products. This is a new requirement for the supply of any COVID-19 test in the UK and is over and above the CE mark and successful registration of Avacta's AffiDX test with the Medicines and Healthcare products Regulatory Agency (MHRA) which was announced in June this year.
The new regulation stipulates that all suppliers of COVID-19 tests must submit information regarding their products for desktop review if they wish to remain on sale in the UK.
The AIM-listed company said it submitted the information required for its test to be validated under these regulations and paid the fee required by the 1st September deadline. However, the company is still awaiting further notification from the UK Health Security Agency when it completes its review of the information supplied for the lateral flow test.
The company said the impact of the suspension of sales in the UK as a result of the regulations will not have a material impact on the anticipated outturn for the financial year ending 31st December 2021.
Nevertheless, as of 08:56BST, Avacta shares were trading lower by 7.7% at 111.68 pence per share.