NEW YORK ─ Avacta on Friday announced that it has obtained the CE mark for its AffiDX SARS-CoV-2 antigen lateral flow test, enabling its availability for professional use in the European Union.
The antigen test provides a cost effective and rapid means of identifying individuals with high viral loads, meaning they are more likely to infect others, Avacta said. Clinical data has shown that the test has 100 percent sensitivity for identifying infectious individuals with viral loads that have a PCR cycle threshold of less than 27, the firm said.
The test's "performance and ease of nasal sampling coupled with the fact that … [it has] been developed in the UK, is based on UK technology, and is manufactured in the UK are huge selling points for customers in Europe," Alastair Smith, CEO of Avacta, said in a statement.
Wetherby, UK-based Avacta said it has "multiple ongoing commercial discussions with distributors and end-user customers in countries that accept the CE mark for in vitro diagnostic products."
In February, Avacta inked an agreement to develop, manufacture, and distribute certain of its SARS-CoV-2 tests in collaboration with Mologic.