SARASOTA, Fla. (March 3, 2021) – Lumos Diagnostics, an innovative rapid point-of-care (POC) diagnostics company, announced today a Canadian distribution partnership with Northern Diagnostics to bring the FebriDx® test into Canada. FebriDx is a rapid, in-office POC test that uses a simple fingerstick blood sample to provide clinicians with a rapid assessment of the body’s host immune response to an acute respiratory infection (ARI) spanning from runny nose to sore throat or cough. The FebriDx test helps to differentiate common viral ARIs, including influenza, that may necessitate isolation from bacterial infections that require antibiotic therapy. This can assist not only with proper diagnosing and triage but also reduce the over-prescription of antibiotics, which are ineffective in viral infection.
Northern Diagnostics, based in Winnipeg, Manitoba specializes in the provision of diagnostic medical equipment and POC rapid tests to a customer base ranging from small, privately-owned clinics to national healthcare systems.
“At Lumos, we are constantly growing and striving to increase access to our innovative diagnostic testing solutions for patients in new markets,” said Eric Perreault, chief commercial officer for Lumos Diagnostics. “Northern Diagnostics is an ideal partner to bring the FebriDx test into Canada. Their in-depth knowledge of the healthcare industry, strong relationships and market presence will ensure that this meaningful test is available to patients when and where they need it most.”
Patients with ARI frequently present to a general practitioner’s office or emergency room and this accounts for the majority of antibiotics prescribed. Based on signs and symptoms alone, it can be difficult for clinicians to confidently and accurately differentiate viral from bacterial infections. By enabling a rapid diagnosis at the initial clinic 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.
The single-use FebriDx test identifies patients within 10 minutes that have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARI through the simultaneous detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP) directly from a fingerstick blood sample. Since MxA is a specific biomarker for viral infections and is known to elevate with all common viral respiratory pathogens, its elevation can identify a viral infection which helps to limit the need for unnecessary antibiotics. An elevation in CRP without MxA helps to confirm a patient with a true bacterial infection that may benefit from antibiotic therapy. The FebriDx test is not intended to diagnose any specific virus or bacteria, including COVID-19.
Clinical performance from two prospective multi-center U.S. clinical trials demonstrates the FebriDx test’s high accuracy and 97-99% negative predictive value to exclude a bacterial infection. Outcome studies show that FebriDx is able to alter clinical management decisions in 48% of patients tested and may reduce unnecessary antibiotic prescriptions by 22-80%.
Trevor Stanson, COO of Northern Diagnostics states, “Through our partnership with Lumos Diagnostics, we will immediately be able to distribute innovative point of care solutions across Canada where they are needed most. Access to innovative healthcare products will significantly improve all our communities during this crucial time of the pandemic. In the coming months, rapid identification of viral and bacterial infections will become even more critical as we attempt to alleviate stress on our workplaces, healthcare system and its employees and get the Canadian people safely back to work.”
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’ 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.
Lumos tests are intended for professional use and should be used in conjunction with other clinical evidence including laboratory, radiographic, and epidemiological information. 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. The COV-ID test is available in specific global markets in compliance with country requirements. COV-ID is not available in Canada. The FebriDx test is an investigational device and limited by Federal Law to Investigational Use in the United States. COV-ID and FebriDx are not commercially available in the U.S. For more information on FebriDx, visit FebriDx.
Lumos Diagnostics announced today the expansion of its board with the appointment of three new independent directors to support the continued growth of the company’s rapid point-of-care diagnostic products and services business.