Avacta Group (LON: AVCT) announced on Monday that the MHRA has confirmed the registration of Avacta's AffiDX SARS-CoV-2 antigen lateral flow test, resulting in its share price climbing over 5%.
The registration allows the company to place the product on the market in the UK for professional use.
The clinical data for Avacta's AffiDX Covid-19 test reported in April showed 100% sensitivity for identifying infectious individuals with viral loads.
Avacta said it has “multiple ongoing commercial discussions” with distributors and customers in countries that accept the CE mark for in vitro diagnostic products.
They expect AffiDX to be registered from a “competent” authority in the EU shortly.
Dr Alastair Smith, CEO of Avacta, commented: “It is a transformative milestone for Avacta's Diagnostics Division being the first CE marked product powered by the Affimer platform that has been brought to market.
“The excellent results of the recent clinical evaluation of the test at a clinical site in Europe demonstrate the test has excellent sensitivity across a range of viral loads, which would be considered infectious.
Smith continued: “We are very excited by the potential of this high-quality SARS-CoV-2 rapid antigen test and by the interest it has already attracted from potential commercial partners and distributors. We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.”
Avacta's share price is currently trading at 252.6p, up 5.65%.
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