Lumos gets FDA approval for its bacteria detecting test, finally moves past its RAT test days

Diagnostic tech company Lumos Diagnostics (ASX: LDX) has received the green card from the US Food and Drug Administration (FDA) to market its FebriDx rapid, point-of-care test in the United States. 

This regulatory clearance permits the marketing of FebriDx in the US as an aid for healthcare professionals in diagnosing bacterial acute respiratory infections and distinguishing them from non-bacterial causes among patients seeking urgent or emergency care. The overprescription of antibiotics fuels a concerning emergence of antimicrobial resistant (AMR) strains of bacterial pathogens. 

In the United States, healthcare professionals in outpatient settings prescribed a staggering 211 million antibiotics in 2021, averaging 636 prescriptions per 1,000 individuals. Alarmingly, acute respiratory infections—primarily caused by viruses—account for the most frequent antibiotic prescriptions, with up to 40% of these prescriptions being deemed unnecessary. In response, the US Centers for Disease Control and Prevention (CDC) Outpatient Antibiotic Stewardship program wants to improve antibiotic prescribing practices among clinicians, ensuring their appropriate use in patients and minimising unnecessary prescriptions.

FebriDx is designed to be used in combination with clinical signs and symptoms, as well as other clinical and laboratory findings, to evaluate patients with acute respiratory infections.

The CEO of Lumos Diagnostics, Doug Ward, said, “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. 

“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 2023.” 

In H1 FY23, Lumos Diagnostics faced a setback when the FDA deemed FebriDx not substantially equivalent to the predicate device (another device used as a point of comparison) used to support its initial 510(k) application. Despite filing an appeal, Lumos received confirmation from the FDA upholding its original decision. However, a pre-submission meeting held in January 2023 provided a glimmer of hope as the FDA indicated that Lumos’ existing clinical and performance data for FebriDx could support a new 510(k) application with narrower claims. Based on this guidance, Lumos resubmitted its application, ultimately achieving a much-needed victory.

The Company rose to popularity during COVID, making and selling RAT tests. However, once the boom subsided, it was left with little, and decided to prioritise products that were commercially viable. Enter FebriDx. 

FebriDx is already registered in several countries, including the UK, Europe, Canada, UAE, Brazil, Turkey, Pakistan, Singapore, Malaysia, and Australia. Now making strides in the US, Lumos Diagnostics’ FebriDx test represents a significant step forward in combating antibiotic resistance by providing healthcare professionals with a reliable tool to differentiate between bacterial and viral acute respiratory infections.

As it prepares for commercialisation, Ward said that the Company will simultaneously keep working with distribution partners and potential licensees, as well as prep its sales team to launch FebriDx in the US.