Lumos Diagnostics Holdings (ASX:LDX) said it started a study of its FebriDx point-of-care test in patients two to 12 years of age in the US to differentiate between bacterial and non-bacterial respiratory infections, according to a Wednesday Australian bourse filing.
The firm said 500 to 800 patients are anticipated to be enrolled across around 20 sites to achieve a sufficient number of positive bacterial cases for the study, over the next 12 months. The first patient has been enrolled in the study.
It is carrying out the study in collaboration with the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, and Biomedical Advanced Research and Development Authority.
The Biomedical Advanced Research and Development Authority is supporting the study with a non-dilutive funding of $6.2 million, triggered if 12 milestone events are achieved, the filing said. The milestones include clinical trial set-up, patient recruitment, US Food and Drug Administration submission, and US FDA granting of a 510(k) clearance and CLIA-waiver categorization.