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US FDA Grants 510(k) Market Clearance To Response Biomedical’s Rapid Respiratory Syncytial Virus Test

Response Biomedical Corporation received a US Food and Drug Administration 510(k) clearance to market a rapid Respiratory Syncytial Virus (RSV) test.

The test which is manufactured by Response Biomedical runs on the RAMP 200 Reader and will be marketed and sold by 3M Health Care as the 3M Rapid Detection RSV Test. The test is a qualitative immunochromatographic assay which is indicated for use as an in vitro diagnostic product with the 3M Rapid Detection Reader (manufactured by Response) to detect the presence of RSV F-protein antigens in nasopharyngeal aspirate, nasopharyngeal swab or nasal wash/aspirate specimens. Measurement of RSV aids in the rapid diagnosis of RSV viral infections in symptomatic patients.

FDA clearance of our rapid RSV test adds another product to the 3M arsenal that addresses the growing need for detecting upper respiratory infections, said S. Wayne Kay, CEO of Response Biomedical. 3M Health Care is expected to introduce this product in the upcoming RSV season, which closely mirrors the influenza season. 3M Health Care currently markets the 3M Rapid Detection Flu A+B Test in the US and is exploring other market expansion opportunities. Having an additional test, which runs on the 3M Rapid Detection Reader, should heighten market interest in these innovative products and, once again, demonstrates the potential of Response Biomedical’s platform technology.