Avacta antigen lateral flow test approved by UK regulator By Investing.com

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Avacta antigen lateral flow test approved by UK regulator

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By Samuel Indyk

Investing.com – Avacta Group’s AffiDX SARS-CoV-2 antigen lateral flow test has been registered by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), allowing the company to place the product on the market in the UK for professional use.

“I am delighted to receive confirmation of the registration of the AffiDX SARS-CoV-2 antigen test from the MHRA,” said Avacta Group (LON:AVCT) CEO Dr Alastair Smith. “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 AIM-listed diagnostics company has said they are in ongoing commercial discussions with distributors and end use customers that accept the CE mark for in vitro diagnostic products.

Avacta also expects product registration from a competent authority within the European Union to follow shortly, providing the gateway for professional use within the bloc.

Lateral flow tests aim to provide a rapid method of identifying individuals with a high viral load, meaning they are more likely to infect others with COVID-19. Avacta’s test demonstrated 100% sensitivity for identifying individuals with viral loads measured by PCR of Ct less than 27.

“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,” Dr Smith added.

“We will continue to focus on its commercial roll-out and manufacturing scale-up to meet demand.”

At 08:31BST, shares in Avacta Group were trading higher by 2.5% at 245.00 pence per share.

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