US-based RPS Diagnostics has received CE mark approval for its FebriDx test, which allows to sell the test in the European Union.
FebriDx has been developed to identify and differentiate a clinically significant immune response to viral and bacterial acute febrile respiratory infection at the point-of-care.
RPS Diagnostics CEO and president Robert Sambursky said that obtaining the FebriDx CE mark is a significant milestone for the company.
"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," Sambursky added.
The test combines the interpretation of both Myxovirus Resistance Protein A (MxA) and C-reactive Protein (CRP).
MxA is an interferon derivative, which becomes elevated in the presence of acute viral infection, and CRP is an acute-phase protein that is elevated in the presence of bacterial infection.
The test can be carried out by a nurse or technician during a patient’s initial workup, by using a fingerstick blood sample, and results can be made available in about ten minutes.
The company has not yet submitted an application for approval with US Food and Drug Administration (FDA).
RPS also provides AdenoPlus test, which helps in the diagnosis of Adenoviral conjunctivitis (pink eye), and InflammaDry test that allows in the diagnosis of dry eye disease.
Image: Single-use FebriDx test kit created by RPS. Photo: courtesy of PRNewsFoto/RPS Diagnostics, Inc.