NEW YORK ─ AnteoTech said on Tuesday that it has obtained CE marking for its EuGeni Reader and COVID-19 Antigen Rapid Test (ART), enabling its use in the European Union and other regions that accept the designation.
The EuGeni COVID-19 Antigen Rapid Test is a single-use, disposable immunochromatographic test for use by healthcare professionals to qualitatively detect the SARS-CoV-2 nucleocapsid antigen in nasopharyngeal specimens collected from people who are suspected of having COVID-19 infection.
The Brisbane, Australia-based company said its COVID-19 antigen test provides results in less than 15 minutes and would support frontline screening as economies look to reopen. Further, its digital reader eliminates human error associated with current lateral flow test interpretation. The reader uses quantitative detection algorithms to eliminate the ambiguity associated with interpreting results, especially when small amounts of target antigen are present, the firm said. Its system can also be integrated into electronic patient records and laboratory information management systems.
The rapid antigen test can process 60 tests per hour, and has demonstrated 97.3 percent sensitivity and 99.6 percent specificity in clinical studies, AnteoTech said.
"As we are rapidly finalizing deals with distribution partners to facilitate large-scale rollout of our COVID-19 ART across Europe in the coming weeks, we’re continuing to refine and mature a promising selection of rapid tests in other disease areas," AnteoTech CEO Derek Thomson said in a statement.
The firm added that it is developing a COVID-19 saliva test for the EuGeni Reader that is undergoing clinical studies, and it is developing a multiplex COVID-19/Flu A & B test and a quantitative multiplex rapid sepsis test for early disease detection.
AnteoTech noted that its EuGeni Platform uses its AnteoBind nanoparticle technology, an aqueous molecular glue used to bind carbohydrate polymers, antibodies, and proteins to synthetic substrates in assay development.