On Feb. 16, 2021, XPhyto and 3a-diagnostics announced that all actions and procedures required for its European regulatory application for the rapid point-of-care SARS-CoV-2 (COVID-19) RT-PCR Test System had been completed. 3a expected ISO 13485 approval as a medical device manufacturer by late February and European regulatory approval as a commercial in vitro diagnostic device (CE-IVD) for Covid-ID Lab by early March.