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Avacta pauses professional sales of its Covid-19 lateral flow test over Omicron sensitivity concerns

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Avacta has paused sales of its Covid-19 lateral flow test, currently in use for professional purposes only, after studies showed it was less sensitive at detecting the Omicron variant at lower viral loads.

The Whittlesford company said its AffiDX SARS-CoV-2 antigen test was shown to be capable of detecting Omicron in patient samples in a small clinical study, as reported, and its own Affimer reagent remained as effective as detecting the variant as it is with Delta.

Avacta CEO Dr Alastair Smith
Avacta CEO Dr Alastair Smith

Further laboratory analysis, however, has showed the antibody it is paired with is affected by the mutations in Omicron. Avacta plans to replace the antibody to maintain the test’s effectiveness.

The test, which was due to be marketed as MeduFlow by Medusa after receiving a CE mark, is not currently available to consumers as it is awaiting approval under the government’s CTDA process.

CEO Dr Alastair Smith said: “The continued high performance of the Affimer reagent in the AffiDX antigen test, despite the large number of mutations in the Omicron variant, is testament to the robustness of our platform technology.

“As a responsible business, we set very high standards for ourselves and our products and have continually kept the performance of the AffiDX antigen test under review as new SARS-CoV-2 variants have arisen. Our determination to only provide high quality, high performance diagnostic tests has led us to the correct decision to pause all marketing of the AffiDX lateral flow antigen test.

Avacta has paused sales of its AffiDX SARS-CoV-2 antigen lateral flow test
Avacta has paused sales of its AffiDX SARS-CoV-2 antigen lateral flow test

“We have, of course, been unable to market the product in the UK since October 2021, as the product continues to await approval under the new CTDA regulatory process.

“We believe Covid-19 testing remains a long-term commercial opportunity. We will therefore use the robustness of the Affimer platform, and what we have learned about the SARS-CoV-2 virus, to generate the next generation antigen test that will be as resilient as possible to any future mutations.

“The performance of other marketed SARS-CoV-2 antigen lateral flow tests may well be adversely affected by the Omicron variant.

“This mutant is already the dominant SARS-CoV-2 variant in many countries and may soon be the dominant variant globally. We therefore believe it is essential that similar Omicron sensitivity studies be performed on all SARS-CoV-2 antigen tests and the results communicated to ensure the public can have confidence in the results these tests generate.”

Read more

Dec 29: Avacta’s Covid-19 lateral flow test AffiDX earns CE mark for consumer use and is due to be marketed as MeduFlow by Medusa

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