Shares of Avacta Group (LON: AVCT) are rallying on Tuesday after the company announced positive data from the clinical validation of its AffiDX® SARS-CoV-2 antigen lateral flow test.
Avacta said data from the clinical study conducted in Europe on 98 positive COVID-19 samples demonstrated “excellent” performance in identifying the SARS-CoV-2 virus across a broad range of viral loads.
The study tested the 98 positive samples with Avacta’s rapid antigen test identifying 96 of them correctly as positive within 20 minutes, resulting in a clinical sensitivity of 98%.
Out of 102 negative samples, the test correctly identified 101 as negative, giving a clinical specificity of 99%.
Avacta stated there is a consensus that a viral load measured by PCR of Ct<27 should be considered infectious, and the clinical data for Avacta's AffiDX® SARS-CoV-2 antigen lateral flow test demonstrated 100% sensitivity for identifying infectious individuals in this range.
The data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® SARS-CoV-2 antigen lateral flow test for professional use, allowing the company to begin commercial roll-out in Europe in May.
“I am delighted with the clinical data from this larger clinical study, which has robustly evaluated the AffiDX® antigen test with lower viral loads of Ct>26 as well as with higher viral load samples. The results are very impressive and marks a major step in obtaining a CE mark for professional use,” said Dr Alastair Smith, CEO of Avacta Group.
Avacta’s share price currently trades at 260p per share, up 10.9% after initially jumping to highs of 291.8p following the news.
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