Thursday, November 01, 2018
RPS Diagnostics, Inc. (RPS®) today announced it has received an updated CE Mark of its FebriDx® test. This clears the way for immediate market introduction in the European Union and in all countries where the CE mark is recognized. FebriDx is a fast, accurate and easy-to-use point-of-care test that is expected to provide a diagnostic solution to the global antibiotic crisis.
FebriDx allows clinicians to assess the body's immune responses to Acute Respiratory Infection (ARI) directly from a fingerstick blood sample within ten minutes. This one-way test identifies patients who have a clinically significant primary infection. It helps to differentiate between viral and bacterial ARIs by rapidly detecting both myxovirus-resistant protein A (MxA) and C-reactive protein (CRP). MxA is an intracellular protein found to be elevated in an acutely occurring viral infection, and CRP is a nonspecific inflammatory protein that is elevated at the onset of any clinically significant infection.
The updated FebriDx test integrates all-in-one plastic housing technology, including a built-in safety lancet, a blood collection and delivery system, and a built-in push-button elimination feature. Overall, the test can be performed more conveniently. No additional equipment is needed to perform the FebriDx test and interpret the results. Through extensive analytical testing and a multicenter study of precision and reproducibility, RPS Diagnostics successfully demonstrated its equivalence with the previous CE-marked version of the product. "The receipt of the updated CE Mark is the starting signal for the first international launch of the FebriDx test," said Robert Sambursky, MD, President and CEO of RPS. "This test will provide a cost-effective outpatient solution to improve antibiotic therapy."
The timely results of the FebriDx test will give clinkers the ability to develop a targeted clinical and therapeutic decision plan the first time they meet the patient. The misuse of antibiotics is a complex global problem that leads to antibiotic resistance and preventable complications and contributes to the rising costs of healthcare, mainly due to diagnostic insecurity and patient pressure. More than 50% of all antibiotic prescriptions are unnecessary and derive from the context of outpatient primary and acute care situations. A recent study in the UK showed In FebriDx, clinical decision-making in 48% of patients tested changed and the number of unnecessary antibiotic prescriptions decreased by 80%. With every day that passes without the implementation of a cost-effective solution, the current global antibiotic crisis is intensifying.
"The elegance of the FebriDx test lies in its simplicity," said Robert Sambursky, MD. "It is important not to miss the treatment of a basic bacterial infection - it is equally important not to prescribe unnecessary antibiotics to patients with a clinically insignificant or viral infection. The focus of most studies and investments in recent years has been on rapid molecular assays to identify specific pathogens. By contrast, FebriDx uses the body's immune system for a comprehensive, fast, accurate, and cost-effective method of identifying which patients might benefit from appropriate antibiotic therapy. "
For more information about the FebriDx test, see FebriDx.com .
RPS Diagnostics
RPS Diagnostics (RPS) is a new developer, manufacturer and marketer of cost-effective point-of-care (POC) testing for responsible use of antibiotics and systemic infectious diseases. The innovative, patented FebriDx® test is a fast one-way test for the practice. A clinically significant immune response can be detected by a fingerstick blood sample, and bacterial causes can be distinguished from viral causes of fever in acute respiratory infection. With a negative predictive value of 97%, FebriDx delivers results in ten minutes and can be used to triage infected patients on their first practice visit. Clinicians receive actionable information which can be used to limit the unnecessary administration of antibiotics. Currently, the FebriDx test has not been approved by the US Food and Drug Administration (FDA) and is not available in the US. For more information about RPS and the company's products, visitRPSdetectors.com .
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Contacts
For RPS Diagnostics
Saranova, LLC
Laura Lovejoy Sambursky, 1 941-928-9025
laura@saranova.net
