Lumos has been awarded approximately $3 million from the Biomedical Advanced Research and Development Authority (BARDA) in support of the clinical study and regulatory submission for the company’s bacterial/nonbacterial point-of-care (POC) respiratory infection test.
Lumos and BARDA, a division of the U.S. Department of Health and Human Services’ Administration for Strategic Preparedness and Response, are partnering to advance the Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission of Lumos’ FebriDx Bacterial/Non-Bacterial test.
Under the collaboration, BARDA will support a clinical study that compares test usage among untrained users and trained users in a CLIA-waived setting. BARDA will also provide regulatory expertise and support for the CLIA-waiver submission to the U.S. Food and Drug Administration (FDA), Lumos and BARDA said in a statement.
FebriDx is an all-in-one, single-use test designed to assess whether an acute respiratory infection is bacterial or nonbacterial in origin. The test kit includes a lateral flow test strip, a built-in retractable safety lancet, a blood collection and transfer tube, and buffer delivery system. The test qualitatively detects elevated levels of two proteins, C-reactive protein (CRP) and Myxovirus resistance protein A (MxA), created by the body’s immune response to help differentiate between bacterial and nonbacterial infections from a fingerstick blood sample.
The test, which currently has 510(k) clearance for moderate and high-complexity use, is designed to help clinicians in decision-making about antibiotic use, the partners said. Achieving a CLIA waiver would allow the test to become available in more healthcare settings, such as doctors’ offices and outpatient clinics, allowing for greater access to rapid testing, they added.