RPS Diagnostics, Inc. (RPS®) today announced CE mark of its FebriDx™ test, clearing the way for sales in the European Union and all countries recognizing the CE mark.
FebriDx is a rapid, disposable, in-office test that helps identify and differentiate a clinically significant immune response to viral and/or bacterial acute febrile respiratory infection at the point-of-care. The FebriDx test combines the interpretation of both Myxovirus Resistance Protein A (MxA) – an interferon derivative that becomes elevated in the presence of acute viral infection, and C-reactive Protein (CRP) – an acute-phase protein that is elevated in the presence of bacterial infection. This novel and proprietary pattern of results provides an accurate way to identify patients suffering from a clinically significant viral and/or bacterial acute febrile respiratory infection from those patients with a microbiologically unconfirmed respiratory illness (MURI).
Using only a fingerstick blood sample, the FebriDx test can be performed by a nurse or technician during a patient's initial workup. Results are available for the clinician in as soon as ten minutes, allowing a treatment plan to be established during the patient's initial visit.
"Obtaining the FebriDx CE mark is a significant milestone for RPS," said Robert Sambursky, MD, chief executive officer and president of RPS. "The FebriDx test will advance our goal to positively impact global healthcare by facilitating an earlier diagnosis, helping to reduce the spread of disease and encourage the judicious use of antibiotics."
Acute febrile respiratory infections represent a major source of morbidity, mortality, and healthcare costs. Identifying a clinically significant respiratory infection and differentiating viral from bacterial etiology during the office visit is challenging because of overlapping symptoms and signs. According to Rattinger et al, more than half of all antibiotics are prescribed to outpatients with acute respiratory infection; many of these prescriptions are not needed and lead to avoidable adverse reactions and antibiotic resistance.
Pending distribution arrangements, the FebriDx test will soon be commercially available in Europe. The test has not yet been submitted for U.S. Food and Drug Administration (FDA) review.
SOURCE RPS Diagnostics, Inc. (RPS)