By Samuel Indyk
Investing.com – Shares in Avacta Group PLC (LON:AVTG) jumped over 11% after the medical diagnostics company announced positive data from its Covid-19 antigen lateral flow test.
Date from the clinical trail of its AffiDX® test, conducted in Europe on 98 positive Covid-19 samples demonstrate excellent performance in identifying the virus across a broad range of viral loads.
The company have said the new data will now be combined with stability and other performance data from ongoing studies to finalise the technical file for CE marking the AffiDX® lateral flow test for professional use, allowing commercial rollout 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,” said Avacta Group CEO Dr Alastair Smith. “The results are very impressive and marks a major step in obtaining a CE mark for professional use.”
Results
From the study, Avacta tested 98 positive samples with various viral loads. The test identified 96 correctly as positive with a 20-minute read time, resulting in clinical sensitivity of 98%.
Out of a total of 102 negative samples tested, the test correctly identified 101 as negative, giving a clinical specificity of 99%.
“We are completing the necessary assessment of the product from our manufacturing partner Global Access Diagnostics, including stability testing that will complete the technical file for CE marking, which we expect will happen in early May,” Smith added.
“We are very excited by the potential of this high quality SARS-CoV-2 rapid antigen test and we are looking forward to updating the market as we commercially roll-out the AffiDX® test in the coming months.”
At 10:55BST, Avacta Group shares were trading higher by 11.0% at 259.95p per share.