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Highlights
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Lumos Diagnostics Holdings Ltd secures nearly $3 million in non-dilutive funding from BARDA for its FebriDx® rapid diagnostic test.
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The funding will support a clinical study for a CLIA waiver and FDA regulatory submission, aiming to expand FebriDx's use in point-of-care settings.
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FebriDx can help improve antibiotic stewardship by enabling clinicians to differentiate between bacterial and non-bacterial infections quickly.
Overview
Lumos Diagnostics Holdings Ltd {OTC:LDXHF} has successfully secured approximately $2.98 million in non-dilutive funding from the U.S. Biomedical Advanced Research and Development Authority (BARDA) for its FebriDx® asset. This rapid diagnostic test is designed to swiftly determine whether an infection is bacterial or non-bacterial, thereby assisting clinicians in making informed decisions regarding antibiotic use.
The funding will primarily support Lumos's planned Clinical Laboratory Improvement Amendments (CLIA) waiver study, as well as the regulatory submission to the U.S. Food and Drug Administration (FDA) for FebriDx. BARDA, which operates under the U.S. Department of Health and Human Services, is collaborating with Lumos to broaden the use of bacterial/non-bacterial testing in CLIA-waived, point-of-care environments. These include physician offices and urgent care clinics, where empirical antibiotic prescriptions are common.
The total potential contract value, contingent upon the exercise of all contract options, could reach $8.26 million. As part of the agreement, BARDA will support a comparative study of test usage between untrained and trained users in a CLIA-waived setting, along with offering regulatory guidance for obtaining the CLIA waiver from the FDA.
Lumos CEO and Managing Director Doug Ward emphasized the importance of the FebriDx test in clinical practice, noting that it provides a rapid and accurate evaluation that can significantly reduce unnecessary antibiotic prescriptions. He expressed gratitude for the partnership with BARDA, highlighting its potential to enhance the test's utility by expanding its application from moderate and high-complexity labs to more accessible healthcare settings.
FebriDx operates as a single-use, visually read diagnostic tool that helps clinicians differentiate between bacterial and non-bacterial acute respiratory infections within approximately 10 minutes, using a fingerstick blood sample to measure two immune response proteins: C-reactive protein (CRP) for bacterial infections and Myxovirus resistance protein A (MxA) for non-bacterial infections. Currently, the test holds 510(k) clearance for moderate and high-complexity settings, with plans for broader implementation in point-of-care environments to improve patient outcomes and address the growing issue of antibiotic overuse and antimicrobial resistance.
Following the announcement of this partnership, Lumos shares saw a notable increase, rising by as much as 16.22% during ASX trading, reaching A$0.043.
