Diagnostics/Covid Test29 Sep 2022 09:17
'The AffiDX ® SARS-CoV-2 antigen lateral flow test, which combined the use of an antibody and an Affimer ® reagent in the test strip, had excellent performance in terms of sensitivity and specificity with the emerging variants of the virus until the Omicron variant appeared in late 2021. The AffiDX ® SARS CoV-2 antigen lateral flow test contained both a proprietary Affimer ® reagent and a commercially available antibody. Our data showed that the Affimer ® reagent in the AffiDX ® test continued to detect the Omicron variant with the same sensitivity as the Delta variant, but the antibody, with which the Affimer ® is paired, had been affected by the additional Omicron mutations.
Early in 2022, the Company independently took the decision to pause sales of the AffiDX ® antigen test whilst it replaces the antibody in the product to ensure that its performance with the Omicron variant matches the high performance with previous mutations.
This re-development is ongoing, and the Company will update the market as soon as it is able to provide a reliable timeline to product re-launch.
The Diagnostics Division is now focused on developing a broader pipeline of new IVD products outside of COVID-19 to drive future revenues and the profitability of the Division. This pipeline is designed to deliver, over the longer term, a full portfolio of IVD products with a focus on decentralised testing for professionals and consumers. The Company is addressing four key areas of respiratory, infectious and cardiovascular disease, cancer and general health and well-being (e.g. hormones, vitamins). The Company is exploring multiple pathways to develop this portfolio of IVD products and revenue as rapidly as possible.'