Lumos Diagnostics (ASX:LDX) has announced that it has received clearance from the US FDA to market its FebriDx rapid point-of-care test in the country.
The clearance allows FebriDx to be marketed in the US for use by healthcare professionals as an aid in the diagnosis of bacterial acute respiratory infection.
The company submitted a new 510(k) application for FebriDx to the FDA earlier this year.
"The FDA has completed its review of this new application and determined that FebriDx has demonstrated substantial equivalence to the predicate device cited in this application, and has consequently cleared it for marketing in the US," said the company.
FebriDx is now registered in the US, UK, Europe, Canada, UAE, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia.
“We are delighted to finally secure clearance to market our FebriDx rapid, point-of-care test in the US as we continue to believe it has an important role to play in antibiotic stewardship,” said Doug Ward, CEO of Lumos Diagnostics.
“It is a credit to the Regulatory team at Lumos that we have been able to deliver this outcome from our new 510(k) application significantly ahead of our initial expectations. With this clearance in hand, we anticipate securing our first commercial orders in the US before the end of calendar year 2023. In the meantime, we are continuing to work with distribution partners and potential licensees, as well as establish our own focused sales effort, as we prepare to launch FebriDx in the US.”