SARASOTA, Fla. and MELBOURNE, Australia (March 26, 2020) – Lumos Diagnostics and Planet Innovation, its strategic investor and partner, have mobilized a philanthropic effort to provide the FebriDx® diagnostic test to general practitioners (GPs) and other healthcare professionals in the state of Victoria. This initiative will aid in the testing, subsequent triage and timely clinical management of patients presenting with symptoms of an acute respiratory infection (ARI) during these unprecedented times of increased patient demand and concern.
Sam Lanyon, chairman of the board for Lumos Diagnostics and co-chief executive officer for Planet Innovation states, “We are honored to be able to contribute even a small amount to the enormous challenge faced by Victorian and global healthcare providers due to the COVID-19 pandemic. We are working with the Victorian Government to demonstrate the benefits and impact that the FebriDx test may deliver to improving community health by assisting in the initial screening of suspected patients.”
Point-of care (POC) tests such as FebriDx allow results to be rapidly delivered to patients in initial care settings, such as GP clinics, fever screening clinics, hospital emergency rooms and aged care facilities, instead of samples being sent to a laboratory. Unlike pathogen-specific molecular tests, FebriDx is a 10-minute test that rapidly assesses the body’s immune response to an ARI from a simple fingerstick blood sample, helping to identify viral infections that may necessitate isolation and bacterial infections that require antibiotic therapy. The test simultaneously detects two unique biomarkers, Myxovirus resistance protein A (MxA) that becomes elevated in the presence of acute viral infection and C-reactive protein (CRP) that is elevated in the presence of clinically significant infection.
FebriDx is an all-in-one, disposable test that is easy to use in an outpatient setting and/or apply to large scale screening efforts. By enabling a rapid diagnostic triage at the initial visit or screening stage, the FebriDx test can assist health professionals with decision-making and may thereby help identify patients who should undergo further pathogen-specific testing (e.g., coronavirus, Flu A/B) when the FebriDx test result is positive for viral infection and limit unnecessary antibiotic prescriptions that lead to antibiotic resistance when the FebriDx test is negative for bacterial infection.
Clinical performance from a prospective multi-center U.S. clinical trial found FebriDx to be 95% sensitive, 94% specific and have a negative predictive value of 99% to exclude a bacterial infection and a positive predictive value of 90% to confirm viral infection in febrile patients. European outcome studies show that FebriDx is able to alter clinical management decisions in 48% of patients tested and reduce unnecessary antibiotic prescriptions by 80 – 90%.
“The ability to rapidly triage an influx of patients with respiratory infection symptoms as bacterial or viral in the outpatient setting – for example, differentiating high risk patients who may have a viral infection like SARS-CoV-2 and would benefit from confirmatory testing from those with an underlying bacterial infection requiring antibiotic therapy – will improve the flow of care,” said Robert Sambursky, MD, president and chief executive officer of 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 will commercialize 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, Pakistan DRAP registration and is CE marked for sale in Europe. At this time, FebriDx 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.
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A new study in the Journal of Infection by Dr. Tristan Clark, et al. titled “Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19” identifies the FebriDx® test as a rapid, highly accurate, and affordable ‘front door triage tool’ to help healthcare providers differentiate viral from bacterial infection in patients with suspected COVID-19.