Response Biomedical Corp has announced that Roche Diagnostics has agreed to fund two new projects aimed at strengthening the commercial success of Roche’s Response cardiovascular line of products, beginning in 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.

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 (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 is expected to be completed and the CLIA-waiver submission made to the FDA in 2009.

"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% 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.

"We are very excited about expanding our collaboration with Roche Diagnostics," said S. Wayne Kay, Chief Executive Officer, Response Biomedical. "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 cardiovascular product line includes NT-proBNP, Troponin I, CK-MB and Myoglobin tests.

Source: PRNewswire