Yorkshire firm Avacta high precision rapid fire lateral flow test approved for use in the UK by regulators Yorkshire News

Avacta says that Wetherby’s Avacta AffiDX® SARS-CoV-2 Lateral Flow Test is significantly more accurate than other rapid virus delivery tests.

Product registration by the MHRA enables the Company to sell the product in the UK for professional use and the Company expects that product registration by a Competent Authority within the EU will follow shortly.

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Like other lateral flow antigen tests, Avacta’s product is intended to provide a quick and cost-effective means of identifying people with a high viral load, which means they are more likely to infect other people.

Clinical data from the Avacta AffiDX® SARS-CoV-2 Antigen Lateral Flow Test reported in April demonstrated 100% sensitivity in identifying infectious individuals with PCR-measured viral loads of Ct <27.

Avacta said it was now involved in multiple ongoing business discussions with distributors and end-user customers in countries that accept the CE mark for in vitro diagnostic products.

Dr. Alastair Smith, CEO of Avacta Group, said: “I am delighted to receive confirmation of the AffiDX SARS-CoV-2 antigen test registration from the MHRA. It is a transformative milestone for Avacta’s Diagnostics Division as to be the first CE marked product powered by the Affimer platform to be launched on the market.

“The excellent results of the recent clinical evaluation of the test at a clinical center in Europe demonstrate that the test has excellent sensitivity to a variety of viral loads, which would be considered infectious.”

“As part of the study, the same clinical specimens were tested with two commercially available lateral flow antigen tests, and the data shows that the AffiDx® test has superior clinical sensitivity across the entire range of specimens and, in particular, with loads. lower virals.

“We are very excited about the potential of this high quality rapid SARS-CoV-2 antigen test and the interest it has already attracted from potential business partners and distributors. We will continue to focus on its commercial deployment and manufacturing scale. -Up to meet the demand.

“Lateral flow testing has 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 an important role in this process.”

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This notice was published: 2021-06-07 09:25:15

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