Avacta’s Covid-19 lateral flow test AffiDX earns CE mark for consumer use and is due to be marketed as MeduFlow by Medusa

Avacta’s Covid-19 lateral flow test has earned a CE mark for use as a consumer self-test in the UK and EU.

The Whittlesford company has an exclusive agreement with Medusa Healthcare to commercialise the product globally.

Medusa will market the AffiDX SARS-CoV-2 antigen test under the brand name MeduFlow.

It is still awaiting a government desktop review, however, before it can go on sale in the UK.

The nasal swab test, which uses Avacta’s Affimer platform, gives results in 20 minutes. It was clinically validated at the Carlos III Hospital in Madrid and shown to have a sensitivity across a range of viral loads of 98 per cent and a specificity of 99 per cent.

As the Cambridge Independent reported last week, tests at the hospital showed the test was able to detect the Omicron variant. It also detects all other known variants of concern.

It earned its CE mark for professional use in the UK and EU in June 2021.

Dr Alastair Smith, chief executive of Avacta Group, said: “This is an extremely important step forwards in the commercialisation of the AffiDX antigen test. As the pandemic progresses, the global antigen testing market is moving away from professional use antigen tests with increasing adoption of self-test products.”

“The AffiDX test is the first UK-developed SARS-CoV-2 antigen test that has received a CE mark for self-testing which, coupled with the fact that it is based on innovative UK technology and is manufactured in the UK are important selling points for customers in the UK, EU and elsewhere.”

“Our partners at Medusa have rapidly obtained regulatory approval, and we look forward to working closely with them to provide consumers with reliable, high quality tests that address this substantial market.”

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Avacta’ AffiDX antigen lateral flow test able to detect Omicron variant of Covid-19 virus