March 16, the FDA updated its “Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency” document. https://www.fda.gov/media/135659/download
As a result, BioMedomics will be able to distribute our COVID-19 IgM-IgG Antibody Rapid Test to any licensed healthcare practitioner in the United States for diagnostic use starting on March 17, 2020.