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The first project approved for funding is to complete a submission for a CLIA-waiver for the RAMP(R) NT-proBNP assay. NT-proBNP is used in the diagnosis of heart failure. The RAMP(R) NT-proBNP assay has been well accepted as a rapid, accurate test to expedite this diagnosis. In an effort to expand the availability of this system to physician's offices and smaller group practices that are only licensed to perform simple (CLIA-waived) tests, Roche and Response will combine efforts to complete a clinical trial to support CLIA-waived status for the RAMP(R) NT-proBNP assay. The trial is expected to be completed and the CLIA-waiver submission made to the FDA in 2009.
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"The availability of a CLIA-waived NT-proBNP test will open the doors to the use of the Cardiac 200 system in small practices and physician's offices, and will complement current CLIA-waived Roche offerings for blood glucose and oral anticoagulation monitoring," said Bernd Schnakenberg, Head of Decentralized Solutions, Roche Professional Diagnostics.
The next project Response will undertake, is a next-generation Troponin I (TnI) assay development. Troponin I is a critical part of the diagnosis of heart attacks or acute myocardial infarction, especially for the more than 50 percent of cases where an electrocardiogram is inconclusive. The development of the improved RAMP(R) TnI test will re-align the results obtained to more closely reflect those obtained on the most commonly used central laboratory analyzers.
"We are very excited about expanding our collaboration with Roche Diagnostics," said S. Wayne Kay, Chief Executive Officer, Response Biomedical. "Roche is one of the largest in vitro diagnostics companies in the world, and we could not ask for a stronger partner to commercialize our cardiovascular product line. We have already begun work on these two important projects and Roche's support will allow us the ability to focus key resources to advance the cardiovascular product line while conserving cash outlays by Response."
The RAMP(R) cardiovascular product line includes NT-proBNP, Troponin I, CK-MB and Myoglobin tests.
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, congestive heart failure and influenza.
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 for its Reader and clinical tests and its Quality Management System is registered to ISO 13485: 2003 and ISO 9001: 2000. The RAMP(R) Influenza A/B Assay and RAMP 200 reader are not yet licensed for clinical use in Canada.
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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SOURCE Response Biomedical Corp.
