NEW YORK — AnteoTech said on Wednesday that it has received a CE marking for an updated version of its EuGeni COVID-19 Rapid Antigen Test.
The test first received the CE mark in April 2021 as a single-use, disposable immunochromatographic test for use in qualitatively detecting the SARS-CoV-2 nucleocapsid antigen in nasopharyngeal specimens collected from people who are suspected of having COVID-19 infection.
According to the Brisbane, Australia-based firm, the updated test is designed to also use combined nose and throat samples, as well as mid-turbinate specimens.
AnteoTech said that to establish its new use claims, it completed analytical and clinical performance evaluations in the US and UK, respectively, focusing on validating the test's ability to detect the Omicron variant of the SARS-CoV-2 virus. That work will be used in future regulatory submissions. The firm is also currently conducting a clinical trial in Europe evaluating the updated multiple-use claim to include the test in the EU Common List registration application.
AnteoTech said it plans to phase out the original nasopharyngeal test as it receives more orders for the updated test.