Economic Evaluation of Lumos Diagnostics� FebriDx� Point-of-Care Test Highlights $2.5 Billion in Potential U.S. Healthcare Cost Savings Annually

Journal of Health Economics and Outcomes Research Publishes Cost Impact of the Novel, Rapid Point-of-Care Test

SARASOTA, Fla.–(BUSINESS WIRE)–#ASX–Lumos Diagnostics (ASX: LDX), a leader in rapid point-of-care (POC) diagnostic technologies, today announced that the Journal of Health Economics and Outcomes Research (JHEOR) has published an economic study that concludes using the FebriDx� test to guide antibiotic treatment for patients presenting with acute respiratory infections (ARIs) could potentially result in $2.5 billion of annual cost saving for the U.S. healthcare system.

The journal article, authored by Avalon Health Economics, is entitled, “Economic Evaluation of FebriDx®: a Novel Rapid, Point-of-Care Test for Differentiation of Viral versus Bacterial Acute Respiratory Infection in the United States.”¹ According to the study, the diagnostic accuracy of FebriDx to distinguish between bacterial and viral ARIs has been evaluated in multi-center U.S. clinical trials. The FebriDx test was determined to have both high sensitivity (up to 95%) to detect a bacterial infection and up to 99% negative predictive value (NPV) to safely rule out a bacterial infection.

“Rapid, accurate and actionable information can help increase diagnostic certainty and reduce healthcare costs,” said John Schneider PhD, CEO of Avalon Health Economics. “FebriDx is a simple fingerstick blood test that differentiates viral from bacterial acute respiratory infection within 10 minutes and thereby helps doctors focus antibiotic treatment where it is needed to combat the growing threat of antibiotic resistance.”

The potential cost savings attributed to using FebriDx are based on a budget impact model developed by Avalon Health Economics that uses published data from 2010 to 2020. The model considers the total cost of antibiotic treatment, antibiotic resistant infections, antibiotic-related adverse events, and point-of-care testing on a national level. Key data referenced in the article include:

• There are more than 150 million outpatient and emergency department (ED) visits for ARIs each year in the U.S. and about half of the antibiotics prescribed during these visits are considered medically unnecessary.
• According to the U.S. Centers for Disease Control and Prevention, 2.8 million antibiotic resistant infections occur annually in the U.S., 35,000 of which are fatal including complications from Clostridium difficile (C-diff) infections.
• Antibiotic-related adverse events are a common cause of both hospitalizations and ED visits, accounting for over 16% of all outpatient adverse drug event visits.
• Outpatient settings are an important focus for future antibiotic stewardship as they account for 59% of all antibiotic expenditures from 2010 to 2015.

Key drivers of antibiotic misuse include difficulty differentiating viral from bacterial infection due to overlapping clinical presentation and long laboratory-based testing turnaround times. This diagnostic uncertainty, coupled with clinician concern about missing bacterial infections, as well as patient expectation of receiving a prescription, can lead to inappropriate antibiotic prescriptions. This economic analysis determines that using FebriDx to manage patients with suspected ARIs in outpatient settings may lead to a considerable reduction in unnecessary antibiotics, which could lead to a reduction in antimicrobial resistance and adverse events.

The study highlighted potential for meaningful cost savings even though the study’s budget model excluded other notable cost factors such as:

• Potential cost savings due to enhanced workflow and efficiency in emergency and urgent care settings
• Rapid identification of bacterial infection and reduced risk of morbidity or sepsis associated with delayed treatment
• Costs and delays associated with other testing
• Acceleration of antimicrobial resistance and so called “superbugs” associated with the ongoing COVID-19 pandemic

The FebriDx test is under review and these intended use and performance claims have not been approved by the U.S. Food and Drug Administration (FDA). FebriDx is not currently available for sale in the U.S. FebriDx is approved by the corresponding regulatory agencies and available to qualified healthcare providers in Europe, Canada and Australia.

The study published in the JHEOR can be accessed at https://doi.org/10.36469/001c.27753.

¹ Dick, Katherine, and John Schneider. “Economic Evaluation of FebriDx®: A Novel Rapid, Point-of-Care Test for Differentiation of Viral versus Bacterial Acute Respiratory Infection in the United States.” Journal of Health Economics and Outcomes Research 8.2 (2021): 56-62.

About Lumos Diagnostics

Lumos Diagnostics specializes in rapid, cost-effective, and complete point-of-care (POC) diagnostic test technology to help healthcare professionals more accurately diagnose and manage medical conditions. Lumos offers customized assay development and manufacturing services for POC tests and proprietary digital reader platforms. Lumos also directly develops, manufactures, and commercializes novel Lumos-branded POC tests that target infectious and inflammatory diseases.

For more information visit lumosdiagnostics.com or febridx.com.

Forward-Looking Statements

This announcement contains forward-looking statements, including references to forecasts. Forward-looking statements are not guarantees of future performance and involve known and unknown risks, uncertainties, assumptions, and other important factors, many of which are beyond Lumos’ control and speak only as of the date of this announcement. Readers are cautioned not to place undue reliance on forward-looking statements.

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Investor Contact:
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