BG Medicine Obtains CE Mark and Files 510(k) for Expanded BGM Galectin-3 Indication

BG Medicine, Inc. BGMD announced today that it has filed a 510(k) Premarket Notification with the U.S. Food and Drug Administration (FDA) for regulatory clearance of an expanded indication for its BGM Galectin-3 test. The blood test was cleared by the FDA in November 2010 and is currently indicated for use in patients with chronic heart failure who are at increased risk for hospitalizations or death based on elevated levels of galectin-3. Subject to FDA clearance, the new application would expand the indicated use to the general adult population to identify those with an elevated level of galectin‑3, which is associated with an increased risk for new‑onset heart failure. The Company also announced that it has obtained CE Mark in the European Union (EU) for the expanded indication for the BGM Galectin-3 test, and is working with its partners to begin commercialization for the expanded indication in the EU. The validation study that supports the expanded indication was conducted by the Framingham Heart Study. Led by the National Heart Lung and Blood Institute (NHLBI), the Framingham Heart Study (FHS) is a leading, prospective, observational, family multi-generational study designed to track the development of cardiovascular disease and elucidate its common contributing factors. The study was initiated in 1948 and is a widely-used, generally-accepted, authoritative source that addresses risk factors associated with cardiovascular risks and disease. The study reported that approximately 15% of the general adult population was found to have elevated levels of galectin-3. Individuals with elevated levels of galectin-3 had a clinically important and statistically significant 47% increase in risk for the development of new-onset heart failure.