Healthcare Industry News: influenza
News Release - July 29, 2009
Response Biomedical Receives U.S. FDA 510(k) Market Clearance of Rapid Respiratory Syncytial Virus TestVANCOUVER, July 29 --(HSMN NewsFeed)-- Response Biomedical Corporation (TSX: RBM, OTCBB: RPBIF) announced today that it received a U.S. Food and Drug Administration (FDA) 510(k) clearance to market a rapid Respiratory Syncytial Virus (RSV) test.
The test manufactured by Response Biomedical runs on the RAMP(R) 200 Reader and will be marketed and sold by 3M Health Care as the 3M(TM) Rapid Detection RSV Test. It is a qualitative immunochromatographic assay indicated for use as an in vitro diagnostic product with the 3M(TM) Rapid Detection Reader (manufactured by Response) to detect the presence of RSV F-protein antigens in nasopharyngeal swab, nasopharyngeal aspirate, 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(TM) Rapid Detection Flu A+B Test in the U.S. and is exploring other market expansion opportunities. Having an additional test, which runs on the 3M(TM) Rapid Detection Reader, should heighten market interest in these innovative products and, once again, demonstrates the potential of Response Biomedical's platform technology."
About Response Biomedical
Response Biomedical develops, manufactures and markets rapid on-site diagnostic tests for use with its RAMP(R) Platform for clinical and environmental applications. RAMP(R) 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(R) 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(R) clinical tests are commercially available for the early detection of heart attack and congestive heart failure.
In late 2006, the Company formed a strategic alliance with 3M Company to commercialize rapid infectious disease tests. In the non-clinical market, RAMP(R) 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 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.
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Given these uncertainties, assumptions and risks, readers are cautioned not to place undue reliance on such forward-looking statements or information. We disclaim any obligation to update, or to publicly announce any revisions to, any such statements or information to reflect future results, events or developments, except as required by law.
Source: Response Biomedical
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