22nd Feb 2021 09:28
(Alliance News) -Â Avacta Group PLC on Monday noted press reports over the UK government's take-up of its lateral flow SARS-CoV-2 rapid antigen test, and said it is focusing on the full clinical validation of its nasal swab-based test.
Shares in the developer of Affimer biotherapeutics and reagents were up 13% at 207.36 pence each in London on Monday.
As announced earlier in 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.
Avacta 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 firm said a press report over the 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," said Avacta.
While Avacta "continues to be in dialogue" with the UK Department of Health & Social Care, 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," the company said.
By Lucy Heming;Â [email protected]
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