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Lumos Diagnostics Holdings Ltd (ASX:LDX) has received a significant boost to its development of FebriDx – a test which uses a blood sample to show if a patient has a bacterial infection – with a US government department coming on board to support a study and FDA (Food and Drug Administration) application to the tune of nearly US$3 million.
Lumos has received US$2,984,571 in non-dilutive funding from the Biomedical Advanced Research and Development Authority (BARDA) for an upcoming Clinical Laboratory Improvement Amendments (CLIA)-waiver clinical study and regulatory submission for its FebriDx bacterial/non-bacterial test.
The clinical study compares usage of the test among untrained users in CLIA-waived settings to trained users. The goal is to provide regulatory expertise, and aid the submission in obtaining a CLIA-waiver from the FDA.
The waiver will mean that FebriDx can be used in settings such as physician offices, urgent care clinics, or other outpatient clinics.
BARDA – which is part of the US Department of Health and Human Services’ Administration for Strategic Preparedness and Response – is plugging funding into the study, boosting FebriDx’s status as a crucial product to support doctors in determining the use of antibiotics in medical settings.
Lumos’ CEO and managing director Doug Ward said the partnership was an important step in driving development of the FebriDx test.
“Since early clinical practice, doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions,” he said.
“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 honored 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.”
If all contract options are exercised, the total value of the contract with BARDA will reach US$8,258,774.
Lumos’ share price rose on the news, and at 11:03 AEST, shares were trading at 4.1 cents – a rise of 10.81% since the market opened.
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