NEW YORK – OraSure Technologies announced on Thursday its DNA Genotek subsidiary has obtained regulatory authorization in Canada for its OMNIgene ORAL (OME-505) saliva collection device for use as a component in molecular diagnostic tests for the detection of SARS-CoV-2.
Health Canada's Interim Order authorization will permit diagnostic labs, provincial and territory health authorities, and COVID-19 test kit providers to offer testing more broadly, including for at-home self-collection and healthcare professional collection, OraSure said in a statement.