BGM Galectin-3 test regulatory update
BG Medicine said it received CE Mark approval for the first automated version of the BGM Galectin-3 heart failure risk test to measure galectin-3 for use in the prognosis of patients with heart failure (HF). The blood-based test measures galectin-3, a soluble beta-galactoside-binding lectin associated with the formation of cardiac fibrosis, in human plasma or serum. BG Medicine added that it expects to open a CLIA-certified laboratory this half to make galectin-3 testing available to more hospitals.
bioMerieux plans to launch the test in the EU this year and distribute the product through its VIDAS immunoassay platform. bioMerieux is 1 of 4 partners to commercialize automated versions of the test. BG Medicine has partnerships with Abbott, Alere, and bioMerieux to develop and commercialize automated versions of the Galectin-3 test for various IT platforms. ...