BioPorto A/S (CPH:BIOPOR) CEO Peter Eriksen tells Proactive the Danish group expects to complete its clinical study and submit a De Novo application to the FDA for pediatric use of its NGAL kidney test this summer.
Eriksen says in addition, it awaits US test results for the rapid gRAD-based SARS-CoV-2 assay; if positive, and will then proceed towards US FDA Emergency Use Authorization (EUA) and European CE mark submissions in the second quarter of 2021.