Avacta Group plc (AIM: AVCT), a clinical stage biopharmaceutical company developing innovative cancer therapies and powerful diagnostics based on its proprietary Affimer® and pre|CISION™ platforms, notes that, as of 1 November 2021, the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021 (“CTDA regulations”) have come into force. Consistent with these new regulations the Company has suspended, as of 1 November 2021, further sales of its AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test in the UK until the ongoing desktop evaluation of the test has been successfully completed by the Agency and the test subsequently is 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 Company’s AffiDX® test with the MHRA which was announced on 7 June 2021.
The new CTDA Regulations stipulate 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. As of 1 November 2021, there were only three products for which the Agency had completed its desktop review listed on the CTDA register for approved products. Additionally, the UK Health Security Agency has published a temporary protocol which lists 48 tests (both PCR and antigen based) which passed the Public Health England validation process at Porton Down earlier in the year that can remain available for sale in the UK whilst their validation is completed until a cut-off date of 28 February 2022.
Avacta submitted, ahead of the 1 September 2021 deadline, all the information required for its AffiDX® test to be validated under these regulations by the UK Health Security Agency, and the Company has paid the required fee. The Company awaits further notification from the UK Health Security Agency when it completes its review of the information supplied for the AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test.
The impact of suspension of sales in the UK as a result of the CTDA regulations coming into force will not have a material impact on the Company’s anticipated financial outturn for the financial year ending 31 December 2021. As previously noted, Avacta continues to focus on opportunities outside of the UK for the sale and marketing of its AffiDX® SARS-CoV-2 Lateral Flow Rapid Antigen Test including markets in Europe and further afield.