- Lumos Diagnostics (LDX) receives clearance from the US Food and Drug Administration (FDA) to market its FebriDx rapid, point-of-care test
- FeriDx can be marketed in the US as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial causes
- Lumos resubmitted its application in January despite already being registered in countries around the world
- LDX CEO Doug Ward hopes the test will be commercially available by the end of the year
- Shares in LDX are up 327 per cent to 4.7 cents at 12:22 pm AEST
Lumos Diagnostics (LDX) has received clearance from the US Food and Drug Administration (FDA) to market its FebriDx rapid, point-of-care test.
The approval means FeriDx can be marketed in the US as an aid in the diagnosis of bacterial acute respiratory infection and differentiation from non-bacterial causes.
The point-of-care test will only be allowed to be used by healthcare professionals, alongside clinical signs and symptoms to evaluate patients with a potential acute respiratory infection.
This comes after FeriDx was rejected by the FDA last year after the organisation reported the test could result in the further spread of COVID-19.
Lumos resubmitted the application in January this year and has already been registered in countries such as the United Kingdom, Europe, Canada, Turkey and Australia.
“With this clearance in hand, we anticipate securing our first commercial orders in the US before the end of the calendar year 2023,” LDX CEO Doug Ward said.
“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.”
The test was developed to stop doctors from over-prescribing antibiotics, with antibiotic resistance becoming a major health issue in Western medicine.
Shares in LDX were up 327 per cent to 4.7 cents at 12:22 pm AEST.