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Lumos Diagnostics secures US government funding to develop groundbreaking FebriDx test

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By Colin Hay - 
Lumos Diagnostics ASX LDX BARDA FebriDx CLIA Waiver Study
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Lumos Diagnostics (ASX: LDX) has received significant US financial backing for its development of unique point-of-care diagnostic test technology.

Lumos has been awarded approximately $4.3 million by a division of the US government’s health division to support a planned study and regulatory submission for the company’s FebriDx bacterial/non-bacterial test.

FebriDx is designed to assess whether an acute respiratory infection is bacterial or non-bacterial in origin via a visually-read, integrated single-use test.

BARDA funding

The new funding is being provided by the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services.

BARDA will support a clinical laboratory improvement amendments (CLIA) waiver study into FebriDx.

The study will compare test usage among untrained users in a CLIA-waived setting to trained users and also provide regulatory expertise and support for the application to obtain a CLIA waiver from the US Food and Drug Administration.

Powerful diagnostic

Lumos’ chief executive officer Doug Ward said the BARDA support is a significant milestone in the development of FebriDx.

“Doctors have relied primarily on clinical observation to determine whether patients require antibiotics for acute respiratory conditions,” Mr Ward said.

“FebriDx is a powerful diagnostic that can provide a quick and clear clinical evaluation and, in doing so, can reduce over-prescription of antibiotics.”

He added that BARDA’s expertise and the associated funding will support the company’s objective of expanding the test’s utility from its current use in moderate/high complexity labs to US CLIA-waived point-of-care settings including physician offices, as well as urgent care and other outpatient clinics.

Antibiotic stewardship

The FebriDx test will support clinicians with their decisions about antibiotic use and, therefore, has the potential to improve antibiotic stewardship.

FebriDx qualitatively detects elevated levels of two proteins created by the body’s immune response that help differentiate between bacterial and non-bacterial infections in a fingerstick blood sample, with results provided in approximately ten minutes.

Mr Ward said the accelerated results could aid providers in making more informed decisions about patient treatment—which may lead to a reduction in inappropriate antibiotic use.