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Lakewood Ranch-based RPS Diagnostics Inc. received approval from Canadian health department regulators for FebriDx, an in-office test that uses a fingerstick blood sample to identify an immune response to acute respiratory infection.
The Health Canada medical device license allows RPS to sell FebriDx across Canada, according to a statement. The test is also available for sale in Europe but has not been approved by the U.S. Food and Drug Administration.
Acute respiratory infections are often contagious and are associated with flu-like symptoms. The RPS device is disposable after a single use and can show results in 15 minutes, the company says.
“FebriDx will facilitate early identification of contagious patients, reduce spread of disease and support proper use of antibiotics while ultimately saving healthcare costs,” says RPS president and CEO Robert Sambursky in the statement.
RPS Diagnostics, founded in 2004, is a developer, manufacturer and marketer of point-of-care diagnostic tests.
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