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.
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.