The company 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 health failure who are at increased risk for hospitalizations or death based on elevated levels of galectin-3. This unique carbohydrate-binding lectin is associated with increased risk of more aggressive and dangerous forms of heart failure.
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. BG Medicine decided to submit the 510 (k) after a validation study, conducted by the Framingham Heart Study, supported the expanded indication for the company’s test. The study found that 15% of the adult population had elevated levels of galectin-3, and these people had a significant 47% increase in risk for the onset of heart failure.
Heart failure today affects approximately 20 million people in the United States and Europe. Subject to FDA clearance, the expanded indication would address a potential market of roughly 200 people in the United States and Europe. BG Medicine also announced today that it has obtained CE Mark in the European Union for the expanded indication of its test and is working with its partners to begin commercialization for expansion in Europe.
For further information about BG Medicine, its Galectin-3 test and other products, please visit the company’s website at www.bg-medicine.com
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