SARASOTA, Fla. (September 8, 2020) – Lumos Diagnostics today announced its rapid point-of-care (POC) diagnostic test FebriDx® was featured in a Medtech Innovation Briefing (MIB), as part of the United Kingdom’s National Institute for Health and Care Excellence (NICE) guidance for the COVID-19 pandemic response. This MIB addresses the impact that the FebriDx test can have on the concurrent COVID-19 pandemic and antimicrobial resistance global health crises.
In compiling the MIB, NICE obtained feedback from clinical experts, all of whom considered the FebriDx test to be innovative and novel. The MIB advised that the CE marked FebriDx test could be used in the primary or secondary care settings to “help guide the appropriate use of antibiotics” as well as to help with “the early detection of viral infections, such as COVID-19. During the COVID 19 pandemic or pandemics of a similar nature, the technology could also be a way to initially test, triage and isolate individuals presenting to [a] hospital with symptoms associated with the pandemic.” Further, the MIB noted that the ability to use FebriDx to triage patients would “avoid unnecessary use of COVID‑19 treatment resources and facilities.”
“As hospitals and clinics continue to struggle with capacity and patient care during the COVID-19 pandemic, the ability to facilitate prompt and accurate testing is the key to not only better patient care but also an accelerated recovery. FebriDx offers rapid results, which helps clinicians make accurate triage and treatment decisions,” said Robert Sambursky, MD, president and chief executive officer for Lumos Diagnostics. “As the UK continues to work to control the COVID-19 pandemic, the FebriDx MIB will give clinicians critical diagnostic information to improve patient care and therapeutic outcomes, while also protecting their healthcare facilities and communities across the UK.”
Unlike pathogen-specific molecular tests, FebriDx is a 10-minute test that uses a simple fingerstick blood sample to rapidly assess a patient’s immune response to an acute respiratory infection (ARI) – such as sore throat, cough or shortness of breath – at the point of care. FebriDx detects viral ARIs including COVID-19 and flu that may necessitate isolation as well as bacterial infections that require antibiotic therapy. This can assist not only with proper diagnosing and triage but also reduce the over-prescription of antibiotics.
FebriDx simultaneously detects two markers, Myxovirus resistance protein A (MxA) that is raised in the blood when there is acute viral infection and C-reactive protein (CRP) that is elevated in the presence of clinically significant infection. An independent study of 251 patients performed at the University of Southampton and recently published in the Journal of Infection identifies FebriDx as a rapid, accurate, and affordable front door triage test to detect viral infection in patients later confirmed to have COVID-19.
Lumos Diagnostics specializes in rapid, cost-effective and complete point-of-care (POC) diagnostic test solutions 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 proprietary, Lumos-branded POC tests that target infectious and inflammatory diseases with unmet diagnostic needs.
Lumos’s current portfolio of tests includes:
- FebriDx®, an all-in-one, disposable, 10-minute, fingerstick blood test that differentiates viral from bacterial acute respiratory infections (ARI).
- COV-ID™; the Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2, a rapid and easy-to-use serology test for the qualitative detection of antibodies to SARS-CoV-2 virus in patients suspected of a history of COVID-19 infection.
Both the FebriDx and COV-ID tests are CE marked for sale in Europe. FebriDx is also registered or licensed with the following other health authorities: Health Canada, Australia TGA, Saudi Arabia FDA, Pakistan DRAP, Singapore HSA, and Malaysia MoH. COV-ID is available in specific global markets in compliance with country requirements. The FebriDx test has not received U.S. 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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New Study Highlights the Utility of the FebriDx® Test for Rapid Triage and Identification of COVID-19
Lumos Diagnostics today announced the publication of a COVID-19 (SARS-CoV-2) clinical trial in The International Journal of Clinical Practice. Kettering General Hospital in the UK prospectively performed a clinical assessment of the FebriDx® point-of-care (POC) fingerstick blood test to rapidly assess and differentiate viral from bacterial symptomatic respiratory infections. The study concluded that FebriDx could be deployed as part of a reliable triage strategy for identifying symptomatic cases as possible COVID-19 in the pandemic.