Shares in diagnostics and cancer therapies company Avacta (AVCT:AIM) gained 5% on Monday to 250.9p after announcing its Covid-19 antigen lateral flow test for professional use had received registration confirmation from the UK’s medicines regulator.
Avacta submitted a Declaration of Conformity for CE mark for its rapid antigen test on 10 May and today’s confirmation means the test can now enter the market.
Products with the CE marking signifies they have been assessed to meet high safety, health, and environmental protection requirements for sale in the European Economic Area.
STRONG EFFICACY
Clinical data showed the test displayed 100% sensitivity for identifying individuals with high viral loads, who are believed to more likely to pass on the virus to others.
In addition, the test showed strong efficacy against a range wide range of viral loads.
Of the 98 patients with positive test samples in the trial, the test correctly identified 96 positive individuals, indicating a high sensitivity reading of 98%. The test correctly identified 101 out of 102 negative test samples, giving a high specificity reading of 99%.
Chief executive Dr. Alastair Smith commented: ‘Lateral flow tests have a crucial role to play in helping our society and economy return to normal, and I am confident that the AffiDX® test will now play a significant part in this process.’
BUILDING COMMERCIAL PIPELINE
The company is in ongoing commercial discussions with distributors and end users which accept the CE mark for clinically proven diagnostic products.
In addition to confirmation of registration from the UK Medicines and Healthcare Products Agency, Avacta expects product registration from a competent authority within the EU to follow shortly.
