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Highlights
- Lumos Diagnostics secures US government funding for FebriDx test development.
- Nearly US$3 million from BARDA to support clinical study and FDA submission.
- FebriDx aims to improve antibiotic use by distinguishing bacterial from non-bacterial infections.
Lumos Diagnostics Holdings Ltd (ASX:LDX) has secured a major boost for the development of its FebriDx test, a diagnostic tool that helps differentiate between bacterial and non-bacterial infections using a blood sample. The company, an ASX healthcare stock, has received nearly US$3 million in funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the US Department of Health and Human Services.
The funding, totaling US$2,984,571, will support a Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and an FDA submission for FebriDx. The study aims to compare the test’s effectiveness between untrained users in CLIA-waived settings and trained professionals. Obtaining a CLIA-waiver would allow FebriDx to be used in outpatient settings such as physician offices, urgent care clinics, and other similar healthcare facilities, expanding its accessibility.
BARDA's Role and Lumos' Vision for FebriDx
The partnership with BARDA highlights FebriDx’s potential to become a crucial tool in improving antibiotic stewardship. The test helps clinicians make more informed decisions about whether a patient requires antibiotics, thereby reducing unnecessary prescriptions. This is particularly valuable in addressing overuse of antibiotics in respiratory infections, which can lead to resistance.
Doug Ward, Lumos’ CEO and managing director, emphasized the importance of this collaboration, noting that the support from BARDA, both financially and through regulatory expertise, would significantly advance FebriDx’s development. Should all contract options be exercised, the total value of Lumos’ contract with BARDA could reach US$8.2 million.
Future Impact and Market Response
If successful, FebriDx’s ability to be used in point-of-care settings such as physician offices and urgent care clinics could have a far-reaching impact on improving diagnostic accuracy and reducing antibiotic misuse. This potential expansion would mark a significant step forward for Lumos and the broader healthcare community.
The market responded positively to the news, with Lumos’ shares rising by 10.81%, trading at 4.1 cents by 11:03 AEST following the announcement.
Lumos Diagnostics’ partnership with BARDA marks a significant milestone for the company’s FebriDx test, aiming to enhance its accessibility and utility in healthcare settings across the United States. The funding and regulatory support will be key to driving the test’s development and expanding its role in combating antibiotic overuse.
