Avacta’ AffiDX antigen lateral flow test able to detect Omicron variant of Covid-19 virus
Avacta has confirmed that its AffiDX antigen lateral flow test is able to detect the Omicron variant of the Covid-19 virus in clinical samples - but the test is still awaiting a desktop review by the UK Health Security Agency.
The LFT uses the Whittleford-based pharmaceutical company’s proprietary Affimer and pre|CISION platforms to detect the virus.
It was evaluated at the Carlos III Hospital in Madrid using a small number of samples from patients with the fast-spreading Omicron variant.
The test also detects all previously identified new variants of concern.
The results represent a boost to Avacta, which had been left frustrated after having to remove the MHRA-approved test from sale when the UK Health Security Agency’s Medical Devices (Coronavirus Test Device Approvals) (Amendment) Regulations 2021, or CTDA regulations, came into effect on November 1.
The regulations stipulated that all suppliers of Covid-19 tests submitted information for desktop review if they wished to remain on sale in the UK, but by that date the UKHSA had only completed the study of three products and granted a temporary protocol for 48 other PCR and antigen-based tests that had earlier passed a Public Health England validation process to remain on sale until February 28.
Avacta, which submitted its test for review in September and paid its fee, does not yet have a date for when it can sell its device again.
Dr Alastair Smith, chief executive of Avacta Group, said: “As this variant is more infectious, it is important that it can be detected in individuals with higher loads using lateral flow tests so that its spread can be slowed down.
“We are progressing with our application to the CTDA in order to put the AffiDx product on the market in the UK, as well as continuing to pursue commercial opportunities in Europe and further afield for the professional-use test.
“We also continue to work with our partners, Medusa 19 Healthcare, to obtain the CE mark for consumer self-testing for the product which is a critical next step in the commercialisation of the product.”