Avacta Group plc (AIM: AVCT), the developer of Affimer® biotherapeutics and reagents, notes the recent press speculation about UK Government take-up of Avacta’s lateral flow SARS-CoV-2 rapid antigen test.
As announced on 16 February, the Company has analysed the first clinical data for its SARS-CoV-2 rapid antigen test from ongoing studies in Europe and the UK. These data show excellent performance of the test in identifying patients with an infectious viral load, with 96.7% sensitivity and 100% specificity using anterior nasal swab samples from 30 COVID-19 positive patients and 26 negative individuals. The Company is now progressing to a full clinical validation with a larger number of patient samples in order to obtain a CE mark for the test for professional use, aiming to bring the test to market in Europe around the end of the first quarter of this year.
The press report this weekend incorrectly stated that a saliva-based rapid antigen test from Avacta had been evaluated at Porton Down. In fact, the evaluated test was the anterior nasal swab test that has subsequently generated the excellent initial clinical performance data outlined above. However, in its evaluation Porton Down used artificial samples and did not use clinical samples.
We believe an accurate, rapid antigen test, that has been appropriately validated, will help to limit the spread of the coronavirus and support the safe return to work and play. In the UK, the DHSC is a potential customer and partner in the roll out of such a validated test. While Avacta continues to be in dialogue with the DHSC, and with other organisations in the UK and abroad, with a view to future supply of its rapid antigen test, it is prioritising the full clinical validation of its nasal swab-based SARS-CoV-2 rapid antigen test as a pre-requisite for CE marking and broad commercialisation.
The Group will update the market fully through the appropriate channels as it reaches significant commercial and technical milestones.