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Highlights
Lumos Diagnostics secures nearly $3 million in funding from BARDA.
The funds will support the FebriDx test’s CLIA waiver study and US FDA application.
The FebriDx test aids in distinguishing between bacterial and non-bacterial infections.
Lumos Diagnostics (ASX:LDX) has been awarded $2.98 million by BARDA, a division of the US Department of Health and Human Services, to support its upcoming study for a CLIA waiver for the FebriDx test. This funding will also aid in the company’s application to the US FDA. The full contract value could reach $8.25 million if all options are exercised, offering significant support for Lumos in advancing its testing capabilities.
The FebriDx point-of-care test is designed to identify whether acute respiratory infections are bacterial or non-bacterial. It works by detecting elevated levels of two proteins associated with the body's immune response: C-reactive protein (CRP) for bacterial infections and Myxovirus resistance protein A (MxA) for non-bacterial infections. The test delivers results within 10 minutes, helping doctors make quicker, more informed treatment decisions and potentially reducing unnecessary antibiotic use.
With its current FDA 510(k) clearance for moderate and high-complexity lab settings, Lumos aims to expand the test’s accessibility through a CLIA waiver, allowing its use in more settings like physician offices, urgent care centers, and outpatient clinics.
BARDA Partnership
BARDA’s funding will support a clinical study that compares the use of FebriDx by untrained users in CLIA-waived settings to trained users. The goal is to secure FDA approval for wider use of the test in simpler, point-of-care settings, ultimately improving patient care by providing rapid, reliable diagnostic information.
Lumos CEO, Doug Ward, emphasized the importance of the FebriDx test in addressing the over-prescription of antibiotics. “FebriDx is a powerful diagnostic tool that can provide quick and clear evaluations, helping reduce unnecessary antibiotic use,” said Ward. He also highlighted the strategic value of partnering with BARDA, noting that their expertise and funding will help expand the test’s utility beyond its current applications.
This partnership, along with the non-dilutive funding from BARDA, will complement Lumos’s ongoing efforts to grow its impact in the diagnostic space.
