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news.Response Biomedical, a developer of rapid on-site diagnostic tests, has announced that Roche Diagnostics has agreed to fund two new projects aimed at strengthening the commercial success of the Response cardiovascular line of products that Roche is expected to market in North America, beginning in this quarter.
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Response Biomedical and Roche Diagnostics signed a strategic partnership in June 2008 to commercialize Response’s cardiovascular tests.
The first project approved for funding is to complete a submission for a Clinical Laboratory Improvement Amendments (CLIA)-waiver for the Ramp NT-proBNP assay. NT-proBNP is used in the diagnosis of heart failure. The Ramp 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 tests, Roche and Response will combine efforts to complete a clinical trial to support CLIA-waived status for the Ramp NT-proBNP assay. The trial is expected to be completed and the CLIA-waiver submission made to the FDA in 2009.
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% of cases where an electrocardiogram is inconclusive.
Wayne Kay, CEO of Response Biomedical, said: We are very excited about expanding our collaboration with Roche Diagnostics. 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.