Point-of-care (POC) tests developer RPS Diagnostics has received updated CE Mark for its FebriDx test to allow incorporation of all -in-one test format.
Image: RPS Diagnostics' FebriDx test. Photo: Courtesy of Business Wire.
RPS Diagnostics can now launch the test in the European Union and all countries that recognize the CE mark.
FebriDx is a simple to use POC test that is anticipated to contribute towards a diagnostic solution to the worldwide antibiotic crisis.
It offers clinicians with a 10-minute evalauation of the body’s immune response to an acute respiratory infection (ARI) directly from a fingerstick blood sample.
The single use, disposable test finds patients who have a clinically significant underlying infection. It supports in the differentiation of viral and bacterial ARIs via the rapid detection of both Myxovirus resistance protein A (MxA) and C-reactive protein (CRP).
The updated FebriDx test features an all-in-one plastic housing technology that includes a built-in safety lancet, blood collection and delivery system and a push button buffer delivery feature, which together can improve test convenience. It needs no additional equipment to perform or to interpret results.
RPS president and CEO Robert Sambursky said: “Obtaining the updated CE mark triggers the initial international commercial launch of the FebriDx test. This test will provide a cost effective outpatient solution to improve antimicrobial stewardship.”
The timely results of FebriDx offer clinicians the ability to formulate a targeted clinical management and therapeutic decision plan during the initial patient encounter. With antibiotic misuse on the rise across the globe, there has been a rise in the antibiotic resistance, avoidable adverse events and it can help lessen healthcare costs.
More than 50% of all antibiotic prescriptions are not needed and are generated in the outpatient primary and urgent care setting.
Sambursky said: “The elegance of the FebriDx test lies in its simplicity. It’s equally important not to miss treating an underlying bacterial infection as it is withholding unnecessary antibiotics from patients with clinically insignificant or viral infection.
“While most research and investment over the past decade has focused on rapid molecular testing to identify specific pathogens, FebriDx utilizes the body’s own immune system to provide a broad, fast, accurate, and cost-effective method to identify patients who may benefit from appropriate antibiotic therapy.”