On Jan. 28, 2021, OraSure Technologies announced its OMNIgene^®·ORAL (OME-505) saliva collection device, a product of Ottawa-based subsidiary DNA Genotek, had received authorization from Health Canada for use as a component in molecular diagnostic tests for the detection of SARS-CoV-2.

Diagnostic labs, provincial and territory health authorities and COVID-19 test kit providers in Canada now have access to a non-invasive and painless saliva collection device to facilitate expansion of their COVID-19 testing programs.

Health Canada’s Interim Order authorization of OMNIgene^®·ORAL (OME-505) permitted diagnostic labs, provincial and territory health authorities and COVID-19 test kit providers to offer testing more broadly, including for both at-home self-collection and via healthcare professionals. Those adding saliva to their workflow must validate the use of the OMNIgene^®•ORAL with their assay prior to SARS-CoV-2 testing in accordance with applicable regulations.