RPS Diagnostics Announces Canadian Approval of FebriDx® Test to Help Rapidly Differentiate Viral from Bacterial Acute Respiratory Infection at the Point of Care

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RPS Diagnostics, Inc. (RPS®) today announces that Health Canada issued a Medical Device License for FebriDx® – a rapid, in-office test that uses a fingerstick blood sample to help identify a pathogen-induced immune response to viral and/or bacterial acute febrile respiratory infection.

Fingerstick blood sample being pipetted onto the FebriDx test

FebriDx will facilitate early identification of contagious patients, reduce spread of disease, and support proper use of antibiotics while ultimately saving healthcare costs.

RPS Diagnostics, Inc. (RPS®) today announces that Health Canada issued a Medical Device License for FebriDx® – a rapid, in-office test that uses a fingerstick blood sample to help identify a pathogen-induced immune response to viral and/or bacterial acute febrile respiratory infection. A nurse or technician can easily perform the single-use, disposable FebriDx test during a patient’s initial workup and have results available in 15 minutes. This allows an effective patient treatment plan to be established at the point of care.

Acute respiratory infections are often highly contagious and are associated with common flu-like symptoms including, fever, sore throat, cough, nasal congestion, and fatigue. These infections are also a major source of morbidity, mortality, and healthcare costs. More than half of all antibiotics are prescribed for outpatients with acute respiratory infections. Due to overlapping symptoms and signs, it is extremely challenging for physicians to differentiate between viral and bacterial cause of infection during an office visit. By enabling a rapid diagnosis, the FebriDx test helps limit the amount of unnecessary antibiotic prescriptions that can lead to avoidable adverse reactions and antibiotic resistance.

“FebriDx will facilitate early identification of contagious patients, reduce spread of disease, and support proper use of antibiotics while ultimately saving healthcare costs,” said Robert Sambursky, MD, chief executive officer and president of RPS. “Health Canada approval is yet another significant expansion for global access to this innovative test.”

The FebriDx test works by simultaneously detecting elevated levels of Myxovirus resistance A (MxA) – an intracellular protein that elevates in the presence of acute viral infection, and C-reactive Protein (CRP) – an acute-phase protein that increases in the body when a bacterial infection is present. The combined detection of MxA and CRP facilitates the differentiation of patients more likely to have an acute viral and/or bacterial infection from less clinically significant microbiologically unconfirmed respiratory illnesses (MURI).

The Health Canada Medical Device License allows the FebriDx test to be marketed and sold in Canada. The FebriDx test is also CE marked and available for sale in Europe. However, the test has not yet received clearance from the U.S. Food and Drug Administration (FDA) and is not commercially available in the United States. To learn more, visit FebriDx.com.

About RPS
Founded in 2004, RPS Diagnostics (RPS) is an emerging developer, manufacturer, and marketer of rapid point-of-care (POC) diagnostic tests. RPS Diagnostics is a trade name of Rapid Pathogen Screening, Inc., a wholly owned subsidiary of RPS Diagnostics, Inc. The company’s innovative and patented technology platform facilitates the development of a spectrum of cost-effective tests to support the rapid, in-office diagnosis of patients with infectious diseases and inflammatory conditions. As a result of U.S. government contracts, this platform is also being developed to help detect the body’s immune response to viral and bacterial infections as well as chemical nerve agent blood toxins. RPS tests have high sensitivity and specificity, and can be easily performed by a clinician or their staff without extensive training or additional equipment. Currently available RPS tests include AdenoPlus® to aid in the diagnosis of Adenoviral conjunctivitis (pink eye) and InflammaDry® to aid in the diagnosis of dry eye disease. The FebriDx™ test to assess the clinical significance of an acute febrile respiratory infection and aid the differentiation of viral or bacterial etiology is CE marked and is available in Europe as well as other countries that accept the CE mark. 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 RPS and its products, visit RPSdetectors.com.

Media contact: Laura Lovejoy • laura(at)saranova(dot)net • 941.928.9025

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RPS Diagnostics
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