- Lumos Diagnostics (LDX) has completed all activities to gain regulatory approval in North America for ViraDx, a three-in-one COVID-19/Flu A/Flu B rapid antigen test
- The 15 minute test is used by healthcare professionals to assess patients with acute respiratory symptoms
- The company says with the evolution of the pandemic and new US reports indicating that influenza is on the rise, there is a significant commercial opportunity for ViraDx
- Following necessary regulatory authorisations, ViraDx may complement Lumos’ FebriDx all-in-one, 10 minute test, measuring patients response to acute respiratory infections
- Lumos Diagnostics shares have ended the day 2.9 per cent to close at 67 cents
Lumos Diagnostics (LDX) has completed all activities to support regulatory submissions for ViraDx, a three-in-one COVID-19/Flu A/Flu B rapid antigen test.
Healthcare professionals use the 15 minute test to assess patients with acute respiratory symptoms with regulatory submissions currently underway in the US and Canada.
Lumos Diagnostics president, managing director and CEO, Rob Sambursky, commented.
“We have already commenced preparations for our commercial launch of ViraDx in the North American market,” he said.
“With the evolution of the COVID-19 pandemic, and new U.S. reports indicating that influenza is on the rise and this year’s flu vaccines may not be matched to the predominant strain, we see a significant commercial opportunity for ViraDx.”
Following necessary regulatory authorisations, ViraDx may complement Lumos’ FebriDx all-in-one, 10 minute test, measuring patients response to acute respiratory infections.
“In addition, FebriDx is already approved in Europe, Canada and Australia, and has now received market clearance for the United Arab Emirates (UAE),” Mr Sambursky said.
“An application for regulatory clearance of FebriDx in the US is currently under review by the FDA. Based on recent progress in the FDA’s 510(k) review process, we remain on track to have a decision during FY22.”
Lumos Diagnostics shares were down 2.9 per cent to close at 67 cents.