November 30, 2010

November 30, 2010 (Waltham, Massachusetts) — The FDA has market-approved an assay (BGM Galectin-3, BG Medicine) for galectin-3 to supplement standard risk assessment in patients with chronic heart failure [1]. The biomarker is thought to play a role in myocardial fibrosis and gauge progression of cardiac remodeling in patients with heart failure.

Galectin-3 levels were demonstrated in substudies of several heart-failure trials, including COACH and HF-ACTION, to significantly predict all-cause mortality or hospitalization.

According to Dr Bertram Pitt (University of Michigan, Ann Arbor), quoted in the corporate press release announcing the test's approval, "the availability of a galectin-3 test to identify high-risk patients with cardiovascular disease and myocardial fibrosis represents another step toward the goal of enabling more efficient targeting of therapeutic approaches to reduce fibrosis in patients with chronic heart failure."

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