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.
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, the firm said.
"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 and business unit leader of molecular solutions at DNA Genotek. "This authorization could be transformative for public health efforts in Canada and is an important tool to increase access to testing."
In addition to this authorization from Health Canada, OMNIgene ORAL (OME-505) also has Emergency Use Authorization from the US Food and Drug Administration and has CE marking for in vitro diagnostic use, including for use in COVID-19 testing. The device also was recently selected by Chronomics Limited, a UK-based biotechnology company, as a component of the SARS CoV-2 PCR test it will supply for the UK's Test to Release for International Travel program.