Roche Hopes to Expand Cardiovascular Testing Product Offerings
February 13, 2009 - Roche Diagnostics has agreed to fund two new projects aimed at strengthening the commercial success of the Response Biomedical cardiovascular line of products, which Roche is expected to begin marketing in North America this quarter.
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 CLIA-waiver for the RAMP NT-proBNP assay. NT-proBNP is used in the diagnosis of heart failure. 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 NT-proBNP assay. The trial should be completed and the CLIA-waiver submission made to the FDA in 2009.
Next, Response will undertake 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 TnI test will re-align the results obtained to more closely reflect those obtained on the most commonly used central laboratory analyzers.
The RAMP cardiovascular product line includes NT-proBNP, Troponin I, CK-MB and Myoglobin tests.
For more information: www.responsebio.com.