Biotech Lumos Diagnostics Holdings Ltd (ASX:LDX, OTC:LDXHF) has secured US$2,984,571 in non-dilutive funding from the US Biomedical Advanced Research and Development Authority (BARDA) for its FebriDx® asset, which can rapidly test whether an infection is bacterial or non-bacterial.
Improved antibiotic stewardship
FebriDx can aid clinicians with appropriate antibiotic use decisions and stands to improve antibiotic stewardship in the coming decades.
The funding will support the company’s planned clinical laboratory improvement amendments (CLIA) waiver study and US Food and Drug Administration (FDA) regulatory submission for FebriDx.
BARDA is part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response.
It has partnered with Lumos to expand authorised bacterial/non-bacterial testing to CLIA-waived, point-of-care settings, including US physician offices, urgent care clinics or other outpatient clinics where empiric antibiotic prescription is common practice.
The total contract value, if all contract options are exercised, is US$8,258,774.
BARDA will support the CLIA waiver study, comparing test usage among untrained users in a CLIA-waived setting to trained users.
It will also provide regulatory expertise and support for the application to obtain a CLIA waiver from the FDA.
Powerful, rapid diagnostic
Lumos CEO and managing director Doug Ward said: “Since early clinical practice, doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions.
“FebriDx® is a powerful diagnostic which can provide a quick and clear clinical evaluation, and in doing so, can reduce over-prescription of antibiotics.
“We are honoured to have the opportunity to partner with BARDA on the CLIA waiver study and regulatory submission for FebriDx®.
“BARDA’s expertise and the associated funding will support our objective of expanding the test's utility - from its current use case in moderate/high complexity labs - to US CLIA-waived point-of-care settings, including physician offices, urgent care clinics, or other outpatient clinics.
“Should this goal be achieved, FebriDx’s ability to improve antibiotic stewardship will be vastly expanded.
“The non-dilutive funding received under this contract will be applied to complement those funds raised under the entitlement offer recently open to Lumos shareholders.”
About the FebriDx test
Antibiotics have been overused for many years and this has led to the growing problem of antimicrobial resistance in the community.
FebriDx is a single-use, visually read diagnostic tool that helps clinicians differentiate between bacterial and non-bacterial acute respiratory infections, allowing better decisions to be made about whether antibiotics are necessary.
The test uses a fingerstick blood sample to detect two immune response proteins: C-reactive protein (CRP) for bacterial infections and Myxovirus resistance protein A (MxA) for non-bacterial infections. It provides results in about 10 minutes.
FebriDx is currently approved for moderate and high-complexity use settings with 510(k) Clearance.
Lumos, in partnership with BARDA, is conducting a clinical study to expand its use to CLIA-waived, point-of-care settings such as physician offices and urgent care clinics.
This expansion could improve patient care by offering faster, more accurate diagnoses and reducing misuse and overuse of antibiotics.
Shares higher
News of the partnership has been welcomed by investors with Lumos shares as much as 16.22% higher in ASX trading this morning to $A0.043.