RPS Diagnostics, Inc. (RPS®) today announced an updated CE mark of its FebriDx® test, clearing the way for its immediate launch in the European Union and all countries recognizing the CE mark.
SARASOTA, FL – RPS Diagnostics, Inc. (RPS®) today announced an updated CE mark of its FebriDx® test, clearing the way for its immediate launch in the European Union and all countries recognizing the CE mark. FebriDx is a rapid, accurate, and simple to use point-of-care test that is expected to contribute towards a diagnostic solution to the global antibiotic crisis.
FebriDx provides clinicians with a 10-minute assessment of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample. The single use, disposable test identifies patients who have a clinically significant underlying infection and aids in the differentiation of viral and bacterial ARIs through the rapid detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP). MxA is an intracellular protein that becomes elevated in the presence of acute viral infection and CRP is a nonspecific inflammatory protein that is elevated in the presence of any clinically significant infection. Thus, unlike a standalone CRP test, MxA confers specificity to the test through the combined interpretation of the results.
The updated FebriDx test incorporates an all-in-one plastic housing technology that includes a built-in safety lancet, blood collection and delivery system, and integrated push button buffer delivery feature, which together, improve test convenience. The FebriDx test requires no additional equipment to perform or to interpret results. Through comprehensive analytical testing as well as a multicenter precision and reproducibility study, RPS Diagnostics successfully demonstrated equivalency to the previously CE marked version of the product. “Obtaining the updated CE mark triggers the initial international commercial launch of the FebriDx test,” said Robert Sambursky, MD, president and chief executive officer of RPS. “This test will provide a cost effective outpatient solution to improve antimicrobial stewardship.”
