BG Medicine Announces Receipt of CE Mark for its Galectin-3 Blood Test01/27/2010BG Medicine Initiates Commercialization in the European Union Waltham, MA, USA — January 27, 2010 — BG Medicine, Inc., a privately-held developer of biomarker-based in vitro diagnostics, today announced the commercial launch in the European Union of a new, CE-marked test for the measurement of galectin-3 in human plasma or serum. Galectin-3 was first shown by researchers at the University of Maastricht, The Netherlands, to play an integral role in the development and progression of heart failure. Galectin-3 is a protein that is involved in the biological processes leading to cardiac fibrosis and scarring, which play an important role in heart failure development and progression. Several studies have shown that galectin-3 may provide valuable insight about heart failure and its underlying disease processes. 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. |