Lumos Diagnostics (ASX:LDX) has announced it has received Interim Order authorisation from Health Canada for its ViraDx three-in-one rapid antigen test for COVID-19, Flu A and Flu B.
The company said that subject to demand in Canada, it is ready to commence production and shipping of ViraDx for use by healthcare professionals in the country where it will be distributed by distribution partners.
ViraDx is currently under review by the US FDA. If successful, Lumos said it will expand its North American sales and marketing efforts to include.
“With a single sample, ViraDx provides three simultaneous test results—giving clinicians in outpatient care settings the ability to differentiate these viruses and providing a higher level of confidence as they consider time-sensitive antiviral treatment options,” said Lumos Diagnostics CEO Doug Ward.
“At this stage, the potential demand for ViraDx in Canada is uncertain due to the evolving public health response to COVID-19 and limited reimbursement coverage for POC flu testing. However, this Interim Order authorisation from Health Canada does provide clear validation of the quality of our clinical and regulatory data for ViraDx and an opportunity to co-market it alongside FebriDx. Lumos has an EUA application for ViraDx that is currently under review by the US FDA and is expecting an outcome from that review process in the coming months.”