A Diagnostics & Imaging Week
Response Biomedical (Vancouver, British Columbia) reported that Roche Diagnostics (Basel, Switzerland) 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. Response and Roche signed a strategic partnership in June 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. According to the company, 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 companies expect to complete the trial and submit the CLIA-waiver to the FDA this year.
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 company said. According to Response, 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.
In other dealmaking activity, Emageon (Birmingham, Alabama) said it has received the $9 million that had been placed in escrow with the Bank of New York Mellon by Health Systems Solutions (New York) in connection with the companies' merger transaction. The escrowed funds became payable to Emageon when the merger was not consummated before the close of business on Wednesday.
Emageon also said it has terminated its amended merger agreement with Health Systems due to Health Systems' failure to receive all necessary financing on or before the designated closing date of Feb. 11. Emageon said it "continues to evaluate its options in response to these developments."
Emageon provides information technology systems for hospitals, healthcare networks and imaging facilities.