510(k) Filed for Congestive Heart Failure Test
Response Biomedical Corp. has filed an FDA 510(k) submission seeking clearance to market its RAMP NT-proBNP Test for the diagnosis of congestive heart failure. The Company has also completed a European CE Declaration to market the product in Europe.
NT-proBNP (B-type natriuretic peptide) is a biomarker used widely as an aid in the diagnosis of congestive heart failure and has also been established as a marker for prognosis in Acute Coronary Syndrome (ACS). The regulatory submission follows positive results from the recently completed multicenter clinical trial of the RAMP NT-proBNP Test, developed under license from Roche Diagnostics GMbH. Trials began in August of this year at four US sites, the Mayo Clinic, Minneapolis Medical Research Foundation at Hennepin County Medical Center, Massachusetts General Hospital and San Francisco General Hospital.
In a study conducted at Massachusetts General Hospital, and published in the American Journal of Cardiology September 2006, NT-proBNP testing was associated with a 9.4 percent reduction in costs, translating into savings of US $474 per patient per visit. More than 90 percent of these savings were attributed to prevented or reduced hospitalization (Am J Cardiol 2006; 98(6):800-805; Cost-Effectiveness of Using N-Terminal Pro-Brain Natriuretic Peptide to Guide the Diagnostic Assessment and Management of Dyspneic Patients in the Emergency Department; U. Siebert, J.L. Januzzi, M.T. Beinfeld, R. Cameron, G.S. Gazelle).