FDA grants Response Biomedical a Special 510(k) clearance for the RAMP Influenza A/B Assay

Response BiomedicalOct 22 2009

Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced that the Company has been granted a Special 510(k) U.S. FDA clearance for an update to the Company’s RAMP® Influenza A/B Assay Package Insert to include analytical reactivity information for a strain of the 2009 H1N1 virus cultured from positive respiratory specimens. The RAMP® Influenza A/B Assay is marketed in the United States by 3M Health Care as the 3M™ Rapid Detection Flu A+B Test and is used to identify influenza A and B in human specimens.

Although the RAMP® Influenza A/B Assay has been shown to detect the 2009 influenza A (H1N1) virus in cultured isolates, the performance characteristics of this device with clinical specimens that are positive for the 2009 influenza A (H1N1) virus have not been established. The RAMP® Influenza A/B Assay can distinguish between influenza A and B viruses, but it cannot differentiate influenza subtypes.

“We are very cognizant of physicians’ needs to quickly diagnose influenza and improve patient care in light of a potential influenza pandemic,” said S. Wayne Kay, Chief Executive Officer. “This clearance further validates our technology and combined with our recent RSV clearance will give 3M additional tools to promote the 3M™ Rapid Detection platform to hospitals, which help play a critical role in diagnosing and containing any upper respiratory infection outbreak.”