Lumos Diagnostics receives FDA clearance to market FebriDx in US

Lumos Diagnostics (ASX: LDX) has received clearance from the Food and Drug Administration (FDA) to market its FebriDx rapid point-of-care test in the US.

The FDA determined the diagnostics test had demonstrated “substantial equivalence to the predicate device” cited in a 510(k) pre-market submission made by the company earlier this year.

The product has been cleared for marketing to US healthcare professionals to diagnose bacterial acute respiratory infections and differentiate them from non-bacterial (or viral) causes in patients presenting to emergency care settings.

The test can be used to help in decision making at the point of care to reduce uncertainty, avoid unnecessary antibiotics and enable appropriate patient management.

Results are available within 10 minutes with a 99% negative predictive value (NPV) ruling out a bacterial infection.

FebriDx is already registered in the UK, Europe, Canada, United Arab Emirates, Brazil, Turkey, Pakistan, Singapore, Malaysia and Australia.

Securing clearance and orders

Lumos chief executive officer Doug Ward welcomed the FDA clearance.

“We are delighted to finally secure clearance to market FebriDx in the US as we believe it has an important role to play in antibiotic stewardship,” he said.

“We now anticipate securing our first commercial orders before year end… we are continuing to work with distribution partners and potential licensees, as well as establishing our own focused sales effort, as we prepare to launch FebriDx in the US.”

He said orders for FebriDx from distributors in four European markets remained relatively modest but are “starting to gain momentum”.

Antibiotic resistance

According to medical research, the majority of coughs, colds, sore throats, runny noses and earaches are caused by viruses and do not require antibiotics.

Antibiotic resistance is reported to have become a “major global health threat”, with inappropriate or unnecessary prescribing recognised as a significant contributing factor to the growing global emergence of antimicrobial resistant (AMR) strains of bacterial pathogens.

In 2021, US healthcare professionals in outpatient settings issued 211 million prescriptions for antibiotics — equating to 636 prescriptions per 1000 patients.

“Despite acute respiratory infections being predominantly viral in origin, they are reported to be the most common diagnosis for which antibiotics are prescribed and up to 40% of these prescriptions are considered unnecessary,” Mr Ward said.