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Avacta Obtains CE Mark for COVID-19 Self-Test, Inks Commercialization Deal With Medusa Healthcare

NEW YORK ─ Avacta said Wednesday it has obtained the CE mark for use of its AffiDX SARS-CoV-2 antigen assay as a consumer self-test in the UK and European Union.

The Wetherby, UK-based company said it obtained regulatory approval in partnership with Medusa Healthcare. It has also entered into an exclusive agreement with Medusa to commercialise the consumer self-test globally, and Medusa will market the self-test under the brand name MeduFlow.

Financial and other terms of the agreement were not disclosed.

The SARS-CoV-2 lateral flow test uses its Affimer platform to identify individuals with a high viral load who are more likely to infect others than individuals with a low viral load, Avacta said.

CE marked for professional use in the UK and European Union in June, the device uses a nasal swab and provides a result in 20 minutes, the firm said, adding the test has been clinically validated at the Carlos III hospital in Madrid, showing 98 percent sensitivity across a broad range of viral loads and 99 percent specificity.

In June, the firm announced it had inked a nonexclusive European distribution deal for the AffiDX SARS-CoV-2 antigen lateral flow test with Los Angeles-based Calibre Scientific.

In February, Avacta inked an agreement to develop, manufacture, and distribute certain of its SARS-CoV-2 tests in collaboration with Bedford, UK-based Mologic.