BG Medicine Inc., a Waltham, Massacusetts developer of molecular diagnostics using biomarkers, says that the U.S. Food and Drug Administration (FDA) has cleared the company’s galectin-3 test to help assess the prognosis of patients diagnosed with chronic heart failure. The company says this 510(k) clearance is the first time FDA has cleared a test to measure galectin-3 blood levels.
Galectin-3 is a protein that has been shown to play a role in the development and progression of heart failure in about 30 percent of the patients diagnosed with the disease. This galectin-3 mediated form of heart failure is associated with progressive fibrosis, or stiffening, in the heart muscle, which impairs the heart’s ability to pump. The role of galectin-3 in heart failure was first established in 2004, and the company’s galectin-3 blood test allows physicians to use this product to evaluate patients diagnosed with heart failure.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent (SE), to a legally marketed device. Once the device is determined to be SE, it can then be marketed in the U.S.
BG Medicine is finalizing its commercialization plans with clinical laboratory LabCorp, to make BG Medicine’s galectin-3 test available within 45 days of the FDA clearance. BG Medicine also has agreements with Abbott Laboratories, Alere Inc. , and bioMérieux SA for the development and commercialization of automated versions of the galectin-3 test.
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