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Response Biomedical Obtains Special 510(k) U.S. FDA Clearance to Add Analytical Reactivity Information for the 2009 H1N1 Influenza A Virus to the RAMP® Influenza A/B Assay Package Insert
* Press Release
* Source: Response Biomedical Corporation
* On 7:30 am EDT, Thursday October 22, 2009
VANCOUVER, British Columbia--(BUSINESS WIRE)--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.”
About Response Biomedical
Response Biomedical develops, manufactures and markets rapid on-site diagnostic tests for use with its RAMP® Platform for clinical and environmental applications. RAMP® represents a new paradigm in diagnostics that provides high sensitivity and reliable information in minutes. It is ideally suited to both point of care testing and laboratory use.
The RAMP® system consists of a Reader and single-use disposable test cartridges, and has the potential to be adapted to more than 250 medical and non-medical tests currently performed in laboratories. RAMP® clinical tests are commercially available for the early detection of heart attack, congestive heart failure, influenza and RSV through our commercial partners, Roche and 3M Health Care respectively.
In the non-clinical market, RAMP® Tests are currently provided for the environmental detection of West Nile Virus, and Biodefense applications including the rapid on-site detection of anthrax, smallpox, ricin and botulinum toxin. Several other product applications are under development.
Response has achieved CE Marking for its Reader and clinical tests and its Quality Management System is registered to ISO 13485: 2003 and ISO 9001: 2000.
Response Biomedical is a publicly-traded company, listed on the TSX under the trading symbol "RBM" and quoted on the OTC Bulletin Board under the symbol "RPBIF". For further information, please visit the Company's website at
www.responsebio.com.
