Waltham, MA — February 16, 2010 — BG Medicine, Inc. announced today that the results of a controlled study on the utility of its galectin-3 test in heart failure were published in the Journal Clinical Research in Cardiology, a peer-reviewed, international journal that publishes original research and review articles on clinical research studies in the field of cardiology. The article was recently released and is titled, “Prognostic value of galectin-3, a novel marker of fibrosis, in patients with chronic heart failure: data from the DEAL-HF study,” Dirk J. A. Lok, Peter Van Der Meer, Pieta W. Bruggink-André de la Porte, Erik Lipsic, Jan Van Wijngaarden, Hans L. Hillege and Dirk J. van Veldhuisen. DOI: 10.1007/s00392-010-0125-y.
The study involved 232 patients with a mean age of 71 ± 10 years, of which 72% were male and who generally had advanced heart failure (96% were in New York Heart Association Class III). During a follow-up period of 6.5 years, 98 patients died. Galectin- 3 was determined to be a significant predictor of mortality risk after adjustment for age, gender, renal dysfunction, as measured by glomerular filtration rate, and severity of heart failure, as assessed by NT-proBNP (hazard ratio per standard deviation 1.24, 95% CI 1.03–1.50, P = 0.026).
“This long-term study may provide additional support for the existence of galectin-3 dependent heart failure, in which galectin-3 plays a role in heart failure progression”, said Pieter Muntendam MD, President and CEO of BG Medicine. “Clinical assessment in heart failure previously focused on judging current status, and we believe the addition of galectin-3 as a biomarker may allow physicians to identify patients with this more progressive form of heart failure earlier, so that treatment decisions may be individualized.”
The BGM Galectin-3 test is currently available for clinical use only in the European Union and certain other European countries as an aid in the stratification of patients diagnosed with heart failure. The BGM Galectin-3 test is not available for sale or distribution in the United States or Canada. The Company has submitted a 510(k) application to obtain clearance from the U.S. Food and Drug Administration to sell the test in the United States.
Download the full, licensed article from Clinical Research in Cardiology.
