FebriDx® Wins Biomarkers Award at 2019 UK Diagnostics Summit

Lumos Diagnostics, a point-of-care (POC) diagnostic test developer, manufacturer and marketer received the Biomarkers Award at the recent 2019 UK Diagnostics Summit in Manchester, England for FebriDx^®, a rapid POC test. The 2019 Diagnostics Summit explored existing and emerging novel technologies, platforms and applications from both industry and academic groups that will impact future healthcare delivery and pharmaceutical research.

The FebriDx^® test is easy to use in a POC setting, incorporating a built-in safety lancet to obtain a fingerstick blood sample, a rotating blood collection and transfer system, and an integrated push-button buffer activation. FebriDx^® provides clinicians with a rapid assessment of the body's immune response to an acute respiratory infection (ARI), spanning the spectrum from runny nose, sore throat or cough. The single-use test identifies patients within 10 minutes that have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the simultaneous detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from peripheral whole blood. MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is an acute-phase inflammatory protein that is elevated in the presence of clinically significant infection.

Used alone, CRP is a nonspecific inflammatory biomarker typically reserved to rule out pneumonia in adult patients. The majority of antibiotics are prescribed in the outpatient setting for patients presenting with respiratory symptoms such as runny nose, sore throat and cough. Approximately 50% of viral ARIs, and especially Influenza, stimulate an elevated CRP. "MxA is the key differentiating feature of the FebriDx test," said Eric Perreault, chief commercial officer for Lumos Diagnostics, "it provides the required specificity to the interpretation of the CRP biomarker and improves the utility of CRP, for both pediatric and adult patients, at lower blood levels so that bacterial ARIs are less likely to be missed without unnecessary overtreatment of viral infections."

Pathogen-specific tests are limited to the detection of a single or small group of pathogens. The most commonly used rapid tests target viral antigens, such as tests for Influenza. However, Influenza only comprises approximately 20% of all ARIs. The need to differentiate Influenza is relevant if treatment is planned with antivirals and their value diminishes significantly after the first 36 hours of symptoms. Moreover, pathogen detection cannot differentiate colonization, or subclinical asymptomatic infection from true infection. In contrast, host immune tests identify true infections that require treatment. Since MxA is specific for viral infections and is known to elevate with all common viral respiratory pathogens, it is a universal biomarker for viral infections. Elevation of MxA therefore identifies a viral infection and limits the need for unnecessary antibiotics while an elevation in CRP without MxA would confirm a patient with a true bacterial infection that may benefit from antibiotic therapy.

Clinical performance from two prospective multi-center U.S. clinical trials demonstrate the FebriDx test's high accuracy and 97-99% negative predictive value to exclude a bacterial infection. Moreover, United Kingdom outcome studies show that FebriDx is able to alter clinical management decisions in 48% of patients tested and reduce unnecessary antibiotic prescriptions by 22-80%. By enabling a rapid diagnosis at the initial office visit, the FebriDx test may help to limit the amount of unnecessary antibiotic prescriptions that can lead to avoidable adverse reactions and antibiotic resistance, resulting in lower costs.

Lumos Diagnostics

Lumos Diagnostics provides rapid, cost-effective, and complete point-of-care (POC) diagnostic test solutions that utilize proprietary digital reader platforms to help healthcare professionals more accurately diagnose and manage diseases and medical conditions. Lumos provides assay development and manufacturing services for customized POC tests as well as directly develops, manufactures and commercializes a suite of proprietary Lumos-branded POC tests that focus on the systemic host immune response. Lumos's tests target infectious and inflammatory diseases with unmet diagnostic needs. Actionable results lead to less unnecessary treatments with associated adverse events, reduced spread of disease, and more effective clinical management and therapeutic decisions.

The FebriDx test has received HealthCanada approval, Saudi Arabia FDA clearance, Singapore HSA registration, and is CE marked for sale in Europe. At this time, the FebriDx test has not received U.S. Food and Drug Administration (FDA) clearance and is not commercially available in the United States. For more information on Lumos Diagnostics, visit lumosdiagnostics.com, and for more information on FebriDx, visit febridx.com.