OraSure Subsidiary DNA Genotek’s OMNIgene®·ORAL Saliva Collection Device Receives Health Canada Authorization for use in COVID-19 Testing

IndustryPRwire -- OraSure Technologies announced its OMNIgene®·ORAL (OME-505) saliva collection device, a product of Ottawa-based subsidiary DNA Genotek, has 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) will permit 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.

“Widespread testing for COVID-19 is likely to occur for the foreseeable future, with periods of intense testing required to respond to the local outbreaks that will inevitably arise,” said Kathleen Weber, Executive Vice-President, Business Unit Leader, Molecular Solutions at DNA Genotek. “Providing labs, health units and test kit providers with technology like saliva collection for use at home or supervised by healthcare providers is critical in the fight against COVID-19. This authorization could be transformative for public health efforts in Canada and is an important tool to increase access to testing. As an Ottawa-based company, we are proud that this is now available to help combat the pandemic in Canada and we look forward to working with testing facilities to add our collection kit to their test offerings.”

Self-collected saliva is painless, non-invasive, and can be accessible to everyone unlike nasopharyngeal swabs which require supervision by a healthcare provider. Saliva-based collection is a cornerstone of containing the COVID-19 pandemic, to help identify cases and prevent new outbreaks from emerging.

In addition to this authorization from Health Canada, OMNIgene®·ORAL (OME-505) also has Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration and has CE marking for in vitro diagnostic use, including for use in COVID-19 testing, in the European Union.

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